The Alma Hybrid Laser System

• K Number: K251230
• Device Name: The Alma Hybrid Laser System
• Manufacturer: Alma Lasers, Inc
• Date Cleared: 2025-05-21 ( 30 days)
• Product Code: GEX
• Regulation Number: 878.4810
• Type: Special
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: K103501 , K203441
• Predicate For: N/A

Intended Use

The Alma Hybrid Laser System (Pixel and HyLight CO2 Applicators) is intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including aesthetic surgery (dermatology and plastic surgery), podiatry, gynecology, neurosurgery, orthopedics (soft tissue), arthroscopy (knee). The Alma Hybrid Laser System is cleared for use for the particular indications as follows:

Dermatology & Plastic Surgery
The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:

• Laser skin resurfacing
• Laser dermabrasion
• Laser burn debridement

Laser skin resurfacing (ablation and/or vaporization) for the treatment of:

• Wrinkles, rhytids, and furrows (including fines lines and texture irregularities)

Clinical literature demonstrates that skin resurfacing of wrinkles, rhytids, and furrows with CO2 laser increases the amount of sub-epidermal collagen.

Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of:

• Keratoses, including actinic and seborrheic keratosis, seborrheic vulgaris, seborrheic wart, and verruca seborrhoica
• Vermilionectomy of the lip
• Cutaneous horns
• Solar/actinic elastosis
• Cheilitis, including actinic cheilitis
• Lentigines, including lentigo maligna or Hutchinson's malignant freckle
• Uneven pigmentation/ dyschromia
• Acne scars
• Surgical scars
• Keloids including acne keloidalis nuchae
• Hemangiomas (including Buccal, port wine and pyogenic granulomas/granuloma pyogenicum/granuloma telagiectaticum)
• Tattoos
• Telangiectasia
• Removal of small skin tumors, including periungual (Koenen) and subungual fibromas
• Superficial pigmented lesions
• Aden sebaceous hypertrophy or sebaceous hyperplasia
• Rhinophyma reduction
• Cutaneous papilloma (skin tags)
• Milia
• Debridement of eczematous or infected skin
• Basal and squamous cell carcinoma, including keratoacanthomas, Bowen's disease (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions
• Nevi, including spider, epidermal and protruding
• Neurofibromas
• Laser de-epithelialization
• Trichoepitheliomas
• Xanthelasma Palpebrarum
• Syringoma

Laser ablation, vaporization and /or excision for complete or partial nail matrixectomy.

Vaporization/coagulation of:

• Benign/malignant vascular/avascular skin lesions
• Moh's Surgery
• Lipectomy
• Verrucae and seborrheic vulgaris, including paronychial, perifungal, and subungual warts

Laser incision and /or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty.

Laser incision and /or excision of soft tissue for the creation of recipient sites for hair transplantation.

Podiatry
Laser ablation, vaporization and /or excision of soft tissue for the reduction, removal, and/or treatment of:

• Verrucae vulgaris/plantar (warts), including paronychial, perifungal, and subungual warts
• Fungal nail treatment
• Porokeratoma ablation
• Ingrown nail treatment
• Neuromas/fibromas, including Morton's neuroma
• Debridement of ulcers
• Other soft tissue lesions

Laser ablation, vaporization and /or excision in podiatry for complete or partial matrixectomy.

Otolaryngology (ENT)
Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology the treatment of:

• Choanal atresia
• Leukoplakia, including oral, larynx, uvula, palatal, upper lateral pharyngeal tissue
• Nasal obstruction
• Adult and juvenile papillomatosis polyps
• Polypectomy of nose and nasal passages
• Lymphangioma removal
• Removal of vocal cord/fold nodules, polyps and cysts
• Removal of recurrent papillomas in the oral cavity, nasal cavity, larynx, pharynx and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tongue and vocal cords
• Laser/tumor surgery in the larynx, pharynx, nasal, ear and oral structure and tissue
• Zenker's Diverticulum/pharyngoesophageal diverticulectomy [endoscopic laser-assisted esophageal diverticulectomy (ELAED)]
• Stenosis, including subglottic stenosis; tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil ablation/tonsillotomy
• Pulmonary bronchial and tracheal lesion removal
• Benign and malignant nodules, tumors and fibromas (larynx, pharynx, trachea, tracheobronchial/endobronchial)
• Benign and malignant lesions and fibromas (nose and nasal passages)
• Benign and malignant tumors and fibromas; (oral)
• Stapedotomy/stapedectomy
• Acoustic neuroma in the ear
• Superficial lesions of the ear, including chondrodermatitis nondularis chronica helices/Winkler's disease
• Telangiectasia/hemangioma of larynx, pharynx and trachea (includes uvula, palatal or upper lateral pharyngeal tissue)
• Cordectomy, cordotomy (for the treatment of vocal fold paralysis/vocal fold motion impairment), and cordal lesions of larynx, pharynx and trachea
• Myringotomy/tympanostomy (tympanic membrane fenestration)
• Uvulopalatoplasty (LAUP, laser UPPP)
• Turbinectomy and turbinate reduction/ablation)
• Septal spur ablation/reduction and septoplasty
• Partial glossectomy
• Tumor resection on oral, subfascial and neck tissues
• Rhinophyma
• Verrucae vulgaris (warts)
• Gingivoplasty/gingivectomy

Gynecology (GYN)
Laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for the treatment of:

• Conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia (VIN, VAIN)
• Condyloma acuminate, including cervical, genital, vulvar, perineal, and Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosis (BP) lesions
• Leukoplakia (vulvar dystrophies)
• Incision and drainage (I&D) of Bartholin's and Nabothian cysts
• Herpes vaporization
• Urethral caruncle vaporization
• Cervical dysplasia
• Benign and malignant tumors
• Hemangiomas

GYN Laparoscopy
Vaporization, incision, excision, ablation, or photocoagulation of soft tissue in endoscopic and laparoscopic surgery, including GYN laparoscopy, for treatment of:

• Endometrial lesions, including ablation of endometriosis
• Excision/lysis of adhesions
• Salpingostomy
• Oophorectomy/ovariectomy
• Fimbrioplasty
• Metroplasty
• Microsurgery (tubal)
• Uterine myomas and fibroids
• Ovarian fibromas and follicle cysts
• Uterosacral ligament ablation
• Hysterectomy

Neurosurgery
Laser incision, excision, ablation and/or vaporization and of soft tissue in neurosurgery for the treatment of:

Cranial

• Posterior fossa tumors
• Peripheral neurectomy
• Benign and malignant tumors and cysts (e.g. gliomas, meningiomas (including basal tumors), acoustic neuromas, lipomas and large tumors)
• Arteriovenous malformation
• Pituitary gland tumors (transsphenoidal approach)

Spinal Cord

• Incision/excision and vaporization of benign and malignant tumors and cysts
• Intra- and extradural lesions
• Laminectomy/ laminotomy/ microdiscectomy

Orthopedics
Incision/excision and vaporization and of soft tissue in orthopedic surgery. Applications include:

Arthroscopy

• Meniscectomy
• Chondromalacia
• Chondroplasty
• Ligament release (lateral and other)
• Excision of plica
• Partial synovectomy

General

• Debridement of traumatic wounds
• Debridement of decubitus and diabetic ulcers
• Microsurgery
• Artificial joint revision
• PMMA removal

General/Thoracic Surgery
Incision, excision and vaporization and of soft tissue in general and thoracic surgery including endoscopic and open procedures. Applications include:

• Debridement of decubitus ulcers, stasis, diabetic and other ulcers
• Mastectomy
• Debridement of burns
• Rectal and anal hemorrhoidectomy
• Breast biopsy
• Reduction mammoplasty
• Cytoreduction for metastatic disease
• Laparotomy and laparoscopic applications
• Mediastinal and thoracic lesions and abnormalities
• Skin tag vaporization
• Atheroma
• Cysts, including sebaceous cysts, pilar cysts, and mucous cysts of the lips
• Pilonidal cyst removal and repair
• Abscesses
• Other soft tissue applications

Dental/Oral Surgery
Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include:

• Gingivectomy- removal of hyperplasia
• Gingivoplasty
• Incisional and excisional biopsy
• Treatment of ulcerous lesions, including aphthous ulcers
• Incision of infection when used with antibiotic therapy
• Frenectomy (frenum release)
• Excision and ablation of benign and malignant lesions
• Homeostasis
• Operculectomy
• Crown lengthening
• Removal of soft tissue, cysts and tumors
• Oral cavity tumors and hemangiomas
• Abscesses
• Extraction site hemostasis
• Salivary gland pathologies
• Pre-prosthetic gum preparation
• Leukoplakia
• Partial glossectomy
• Periodontal gum resection

Genitourinary
Incision/excision and vaporization and of soft tissue in genitourinary procedures. Applications include:

• Benign and malignant lesions of external genitalia
• Condyloma
• Phimosis
• Erythroplasia

ProScan
The Alma Hybrid ProScan CO2 fractional applicator, with wavelength of 10600 nm is indicated for:
Laser skin resurfacing (ablation and/or vaporization) of soft tissue.

The Alma Hybrid ProScan 1570nm fractional applicator, with wavelength of 1570 nm, is indicated for: Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue

The Alma Hybrid ProScan CO2 &1570nm fractional applicator, with wavelengths of 10600 nm & 1570nm is indicated for laser skin resurfacing (ablation and/or vaporization) of soft tissue.

Device Description

The Alma Hybrid Laser System consists of:

• Laser system console (containing the optical bench assembly and laser, the microcontroller control electronics and system software, the high voltage power supply, the laser cooling system, the compressed air-purge system, and the service panel)
• LCD control panel with touch-screen technology: the LCD display provides information on the status and settings of The Alma Hybrid Laser System with touch-screen technology provided to input commands into the system.
• Two wavelengths – CO2 and 1570 nm
• Articulated arm
• Footswitch
• Delivery devices (Pixel applicators, Hylight applicators, Proscan applicator)

AI/ML Overview

This document is an FDA 510(k) clearance letter for the Alma Hybrid Laser System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study to prove device performance in the way requested.

Based on the provided text, there is no detailed information described related to acceptance criteria, specific performance metrics, or a study design to "prove the device meets the acceptance criteria" in terms of clinical efficacy. The document is a regulatory submission for substantial equivalence.

Here's an breakdown of the requested information based on the provided text, highlighting what is present and what is absent:

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1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated for efficacy. The document focuses on showing the new device is "substantially equivalent" to predicate devices based on technical characteristics and intended use.
• Reported Device Performance: No quantitative performance metrics are provided in the context of clinical efficacy (e.g., success rates for wrinkle reduction, scar removal, etc.). The tables provided (on pages 16-19) compare technical specifications (like wavelength, spot size, repetition rate, output energy, power) between the subject device and its predicates, and these are deemed "Same" across the devices. For "Indications for Use" (pages 20-43), the subject device's indications are primarily "Same as the Reference Predicate."

Table of Technical Specifications Comparison (Extracted from provided tables; acts as a proxy for 'performance' in this context of substantial equivalence, but not clinical outcomes):

Parameter	Subject Device (Alma Hybrid Laser System)	Primary Predicate (K203441 Alma Hybrid)	Reference Predicate (K103501 Alma Lasers Pixel CO2 Laser System)	Acceptance Criteria (Implied)	Reported Device Performance
Hybrid-Hylight Applicator
Wavelength	10600 nm	10600 nm	10600 nm	Same as Predicates	10600 nm
Pilot beam	650 nm, 3mW	650 nm, 3mW	650 nm, <5 mW	Same as Predicates	650 nm, 3mW
Operation Mode	Repeat pulse/CW	Repeat pulse/CW	Repeat/Super Pulse/CW	Same or equivalent to Predicates	Repeat pulse/CW
Spot size (mm)	0.15 – 3.1 mm	0.15- 3.1 mm	0.125 mm dia spot at tip of spatula at 50 mm / 0.2mm dia. Spot at tip of spatula at 100 mm	Same or equivalent to Predicates	0.15 – 3.1 mm
Repetition Rate	1-5 Hz	1-5 Hz	CW 1-5 Hz	Same as Predicates	1-5 Hz
Pulse Duration	10-1000 ms	10-1000 ms	10-1000 ms for CW	Same as Predicates	10-1000 ms
Min output energy	5 mJ	5 mJ	1 mJ	≥ 1 mJ	5 mJ
Fluence	Max 1746 J/mm2 (30W) / Max 3530 J/mm2 (70W)	Max 1746 J/mm2 (30W) / Max 3530 J/mm2 (70W)	Max 1746 J/mm2 (30W) / Max 3530 J/mm2 (70W)	Same as Predicates	Max 1746 J/mm2 (30W) / Max 3530 J/mm2 (70W)
Pixel Applicator
Spot size (mm)	0.125 to 0.20 mm dia. pixels	0.125 to 0.20 mm dia. pixels	0.125 to 0.20 mm dia. pixels	Same as Predicates	0.125 to 0.20 mm dia. pixels
Repetition Rate	0.5-2Hz	0.5-2Hz	1-5 Hz	Same or equivalent to Predicates	0.5-2Hz
Pulse Duration	1- 405 ms	1- 405 ms	100-300 ms for pulsed	Same or equivalent to Predicates	1- 405 ms
Min output energy	5 mJ/pixel	5 mJ/pixel	Up to 1000 mJ	≥ 5 mJ/pixel	5 mJ/pixel
Max output energy	SW limited to 150 mJ/pixel	SW limited to 150 mJ/pixel	Up to 1000 mJ SW limited to 150	SW limited to 150 mJ/pixel	SW limited to 150 mJ/pixel
Output Power	30 W, 70W	30 W, 70W	30 W, 70W	Same as Predicates	30 W, 70W
1570nm ProScan Applicator
Wavelength	1570nm	1570nm	N/A	Same as Primary Predicate	1570nm
Scan size (mm)	Up to 30mm diameter	Up to 30mm diameter	N/A	Same as Primary Predicate	Up to 30mm diameter
Output energy	24mJ-144mJ/pixel	24mJ-144mJ/pixel	N/A	Same as Primary Predicate	24mJ-144mJ/pixel

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Regarding a "study that proves the device meets the acceptance criteria":

The document explicitly states:

VIII. Clinical Data [21 CFR 807.92(b) (2)]
Based on the similarities in the safety and effectiveness profiles of the subject and the predicate, no human clinical studies were deemed needed to support this submission.

This indicates that no new clinical study was conducted specifically for this 510(k) submission to assess the device's performance against defined clinical acceptance criteria. The clearance is based on substantial equivalence to existing predicate devices, implying that their known safety and effectiveness profiles are sufficient.

---

Given the above, the remaining points cannot be answered from the provided text, as they pertain to clinical study details that were not part of this clearance process.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. No clinical test set or data provenance is mentioned as no human clinical studies were deemed necessary for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. No clinical test set required ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No clinical test set required adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is a laser system, not an AI-powered diagnostic tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a laser system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable. As no new clinical studies were performed, no ground truth was established for "new" clinical data. The substantial equivalence relies on the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

• Not applicable. No clinical training set is mentioned.

9. How the ground truth for the training set was established

• Not applicable. No clinical training set is mentioned.

---

In summary, the provided FDA 510(k) clearance letter demonstrates substantial equivalence of the Alma Hybrid Laser System to previously cleared predicate devices based on technical specifications and intended uses. It explicitly states that no new human clinical studies were required, meaning no specific acceptance criteria for clinical performance were established or tested in the context of this submission. The "acceptance criteria" in this document implicitly refers to meeting regulatory standards and demonstrating equivalent technical and safety profiles to predicate devices.

Summary

FDA 510(k) Clearance Letter - Alma Hybrid Laser System

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID# 04017.07.05
Silver Spring, MD 20993
www.fda.gov

May 21, 2025

Alma Lasers, Inc
Jessica Rivera-Montejo
Director - Regulatory Affairs and Quality Assurance
485 Half Day Rd
Suite 100
Buffalo Grove, Illinois 60089

Re: K251230
Trade/Device Name: The Alma Hybrid Laser System
Regulation Number: 21 CFR 878.4810
Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology
Regulatory Class: Class II
Product Code: GEX, ONG
Dated: March 27, 2025
Received: April 21, 2025

Dear Jessica Rivera-Montejo:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn).

Page 3

Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Tanisha Hithe
Assistant Director
DHT4A: Division of General Surgery Devices
OHT4: Office of Surgical and
Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known): K251230

Device Name: The Alma Hybrid Laser System

Indications for Use (Describe)

The Alma Hybrid Laser System (Pixel and HyLight CO2 Applicators) is intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including aesthetic surgery (dermatology and plastic surgery), podiatry, gynecology, neurosurgery, orthopedics (soft tissue), arthroscopy (knee). The Alma Hybrid Laser System is cleared for use for the particular indications as follows:

Dermatology & Plastic Surgery

The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:

• Laser skin resurfacing
• Laser dermabrasion
• Laser burn debridement

Laser skin resurfacing (ablation and/or vaporization) for the treatment of:

• Wrinkles, rhytids, and furrows (including fines lines and texture irregularities)

Clinical literature demonstrates that skin resurfacing of wrinkles, rhytids, and furrows with CO2 laser increases the amount of sub-epidermal collagen.

Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of:

• Keratoses, including actinic and seborrheic keratosis, seborrheic vulgaris, seborrheic wart, and verruca seborrhoica
• Vermilionectomy of the lip
• Cutaneous horns
• Solar/actinic elastosis
• Cheilitis, including actinic cheilitis
• Lentigines, including lentigo maligna or Hutchinson's malignant freckle
• Uneven pigmentation/ dyschromia
• Acne scars
• Surgical scars
• Keloids including acne keloidalis nuchae
• Hemangiomas (including Buccal, port wine and pyogenic granulomas/granuloma pyogenicum/granuloma telagiectaticum)
• Tattoos
• Telangiectasia
• Removal of small skin tumors, including periungual (Koenen) and subungual fibromas
• Superficial pigmented lesions
• Aden sebaceous hypertrophy or sebaceous hyperplasia
• Rhinophyma reduction
• Cutaneous papilloma (skin tags)
• Milia
• Debridement of eczematous or infected skin

Page 5

• Basal and squamous cell carcinoma, including keratoacanthomas, Bowen's disease (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions
• Nevi, including spider, epidermal and protruding
• Neurofibromas
• Laser de-epithelialization
• Trichoepitheliomas
• Xanthelasma Palpebrarum
• Syringoma

Laser ablation, vaporization and /or excision for complete or partial nail matrixectomy.

Vaporization/coagulation of:

• Benign/malignant vascular/avascular skin lesions
• Moh's Surgery
• Lipectomy
• Verrucae and seborrheic vulgaris, including paronychial, perifungal, and subungual warts

Laser incision and /or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty.

Laser incision and /or excision of soft tissue for the creation of recipient sites for hair transplantation.

Podiatry

Laser ablation, vaporization and /or excision of soft tissue for the reduction, removal, and/or treatment of:

• Verrucae vulgaris/plantar (warts), including paronychial, perifungal, and subungual warts
• Fungal nail treatment
• Porokeratoma ablation
• Ingrown nail treatment
• Neuromas/fibromas, including Morton's neuroma
• Debridement of ulcers
• Other soft tissue lesions

Otolaryngology (ENT)

Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology the treatment of:

• Choanal atresia
• Leukoplakia, including oral, larynx, uvula, palatal, upper lateral pharyngeal tissue
• Nasal obstruction
• Adult and juvenile papillomatosis polyps
• Polypectomy of nose and nasal passages
• Lymphangioma removal
• Removal of vocal cord/fold nodules, polyps and cysts
• Removal of recurrent papillomas in the oral cavity, nasal cavity, larynx, pharynx and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tongue and vocal cords
• Laser/tumor surgery in the larynx, pharynx, nasal, ear and oral structure and tissue
• Zenker's Diverticulum/pharyngoesophageal diverticulum [endoscopic laser-assisted esophageal diverticulectomy (ELAED)]
• Stenosis, including subglottic stenosis; tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil ablation/tonsillotomy
• Pulmonary bronchial and tracheal lesion removal

Page 6

• Benign and malignant nodules, tumors and fibromas (larynx, pharynx, trachea, tracheobronchial/endobronchial)
• Benign and malignant lesions and fibromas (nose and nasal passages)
• Benign and malignant tumors and fibromas; (oral)
• Stapedotomy/stapedectomy
• Acoustic neuroma in the ear
• Superficial lesions of the ear, including chondrodermatitis nondularis chronica helices/Winkler's disease
• Telangiectasia/hemangioma of larynx, pharynx and trachea (includes uvula, palatal or upper lateral pharyngeal tissue)
• Cordectomy, cordotomy (for the treatment of vocal fold paralysis/vocal fold motion impairment), and cordal lesions of larynx, pharynx and trachea
• Myringotomy/tympanostomy (tympanic membrane fenestration)
• Uvulopalatoplasty (LAUP, laser UPPP)
• Turbinectomy and turbinate reduction/ablation)
• Septal spur ablation/reduction and septoplasty
• Partial glossectomy
• Tumor resection on oral, subfascial and neck tissues
• Rhinophyma
• Verrucae vulgaris (warts)
• Gingivoplasty/gingivectomy

Gynecology (GYN)

Laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for the treatment of:

• Conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia (VIN, VAIN)
• Condyloma acuminate, including cervical, genital, vulvar, perineal, and Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosis (BP) lesions
• Leukoplakia (vulvar dystrophies)
• Incision and drainage (I&D) of Bartholin's and Nabothian cysts
• Herpes vaporization
• Urethral caruncle vaporization
• Cervical dysplasia
• Benign and malignant tumors
• Hemangiomas

GYN Laparoscopy

Vaporization, incision, excision, ablation, or photocoagulation of soft tissue in endoscopic and laparoscopic surgery, including GYN laparoscopy, for treatment of:

• Endometrial lesions, including ablation of endometriosis
• Excision/lysis of adhesions
• Salpingostomy
• Oophorectomy/ovariectomy
• Fimbrioplasty
• Metroplasty
• Microsurgery (tubal)
• Uterine myomas and fibroids
• Ovarian fibromas and follicle cysts
• Uterosacral ligament ablation
• Hysterectomy

Neurosurgery

Laser incision, excision, ablation and/or vaporization and of soft tissue in neurosurgery for the

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treatment of:

Cranial

• Posterior fossa tumors
• Peripheral neurectomy
• Benign and malignant tumors and cysts (e.g. gliomas, meningiomas (including basal tumors), acoustic neuromas, lipomas and large tumors)
• Arteriovenous malformation
• Pituitary gland tumors (transsphenoidal approach)

Spinal Cord

• Incision/excision and vaporization of benign and malignant tumors and cysts
• Intra- and extradural lesions
• Laminectomy/ laminotomy/ microdiscectomy

Orthopedics

Incision/excision and vaporization and of soft tissue in orthopedic surgery. Applications include:

Arthroscopy

• Meniscectomy
• Chondromalacia
• Chondroplasty
• Ligament release (lateral and other)
• Excision of plica
• Partial synovectomy

General

• Debridement of traumatic wounds
• Debridement of decubitus and diabetic ulcers
• Microsurgery
• Artificial joint revision
• PMMA removal

General/Thoracic Surgery

Incision, excision and vaporization and of soft tissue in general and thoracic surgery including endoscopic and open procedures. Applications include:

• Debridement of decubitus ulcers, stasis, diabetic and other ulcers
• Mastectomy
• Debridement of burns
• Rectal and anal hemorrhoidectomy
• Breast biopsy
• Reduction mammoplasty
• Cytoreduction for metastatic disease
• Laparotomy and laparoscopic applications
• Mediastinal and thoracic lesions and abnormalities
• Skin tag vaporization
• Atheroma
• Cysts, including sebaceous cysts, pilar cysts, and mucous cysts of the lips
• Pilonidal cyst removal and repair
• Abscesses
• Other soft tissue applications

Dental/Oral Surgery

Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include:

• Gingivectomy- removal of hyperplasia
• Gingivoplasty

Page 8

• Incisional and excisional biopsy
• Treatment of ulcerous lesions, including aphthous ulcers
• Incision of infection when used with antibiotic therapy
• Frenectomy (frenum release)
• Excision and ablation of benign and malignant lesions
• Homeostasis
• Operculectomy
• Crown lengthening
• Removal of soft tissue, cysts and tumors
• Oral cavity tumors and hemangiomas
• Abscesses
• Extraction site hemostasis
• Salivary gland pathologies
• Pre-prosthetic gum preparation
• Leukoplakia
• Partial glossectomy
• Periodontal gum resection

Genitourinary

Incision/excision and vaporization and of soft tissue in genitourinary procedures. Applications include:

• Benign and malignant lesions of external genitalia
• Condyloma
• Phimosis
• Erythroplasia

ProScan

The Alma Hybrid ProScan CO2 fractional applicator, with wavelength of 10600 nm is indicated for:
Laser skin resurfacing (ablation and/or vaporization) of soft tissue.

The Alma Hybrid ProScan 1570nm fractional applicator, with wavelength of 1570 nm, is indicated for: Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue

The Alma Hybrid ProScan CO2 &1570nm fractional applicator, with wavelengths of 10600 nm & 1570nm is indicated for laser skin resurfacing (ablation and/or vaporization) of soft tissue.

Type of Use (Select one or both, as applicable)

☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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K251230 - Special 510(k) Summary

A summary of Special 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92

I. Submitter Information [21 CFR 807.92(a) (1)]

Field	Information
Owner Name	Alma Lasers Inc.
Address	18 Haharash StreetNORTH INDUSTRIAL PARKCAESAREA , IL 3079895
Contact Person	Jessica Rivera-Montejo Assoc. Director of RegulatoryEmail: [e-mail]: [phone]Facsimile: 646-805-1305
Summary Preparation Date	27 March 2025

II. Name of device [21 CFR 807.92 (a) (2)]

Field	Information
Trade or Proprietary Name	The Alma Hybrid Laser System

Common Device Name(s) and Regulatory Class	Product Code(s)	Classification Panel	Regulation
Electrosurgical cutting and coagulation device and accessories Class II	GEX	General & Plastic Surgery Panel, 79 (SU)	§ 21 CFR 878.4810
Powered Laser Surgical Instrument with Microbeam\Fractional Output	ONG	General & Plastic Surgery Panel, 79 (SU)	§ 21 CFR 878.4810

III. Predicate Devices [21 CFR 807.92(a) (3)]

Type	510(k) #	Trade Name	Product Code
Primary	K203441	Alma Hybrid	GEX
Reference	K103501	Alma Lasers Pixel CO2 Laser System	GEX

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Special 510(k) Summary

IV. Device Description [21 CFR 807.92(a) (4)]

The Alma Hybrid Laser System consists of:

• Laser system console (containing the optical bench assembly and laser, the microcontroller control electronics and system software, the high voltage power supply, the laser cooling system, the compressed air-purge system, and the service panel)
• LCD control panel with touch-screen technology: the LCD display provides information on the status and settings of The Alma Hybrid Laser System with touch-screen technology provided to input commands into the system.
• Two wavelengths – CO2 and 1570 nm
• Articulated arm
• Footswitch
• Delivery devices (Pixel applicators, Hylight applicators, Proscan applicator)

V. Intended use of device and Indications for Use [21 CFR 807.92(a) (5)]

Intended Use

The Alma Hybrid Laser System (Pixel and HyLight CO2 Applicators) is intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including aesthetic surgery (dermatology and plastic surgery), podiatry, gynecology, neurosurgery, orthopedics (soft tissue), arthroscopy (knee). The Alma Hybrid Laser System is cleared for use for the particular indications as follows:

Dermatology & Plastic Surgery

The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:

• Laser skin resurfacing
• Laser dermabrasion
• Laser burn debridement

Laser skin resurfacing (ablation and/or vaporization) for the treatment of:

• Wrinkles, rhytids, and furrows (including fines lines and texture irregularities)

Clinical literature demonstrates that skin resurfacing of wrinkles, rhytids, and furrows with CO2 laser increases the amount of sub-epidermal collagen.

Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of:

• Keratoses, including actinic and seborrheic keratosis, seborrheic vulgaris, seborrheic wart, and verruca seborrhoica
• Vermilionectomy of the lip
• Cutaneous horns
• Solar/actinic elastosis
• Cheilitis, including actinic cheilitis
• Lentigines, including lentigo maligna or Hutchinson's malignant freckle
• Uneven pigmentation/ dyschromia

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• Acne scars
• Surgical scars
• Keloids including acne keloidalis nuchae
• Hemangiomas (including Buccal, port wine and pyogenic granulomas/granuloma pyogenicum/granuloma telagiectaticum)
• Tattoos
• Telangiectasia
• Removal of small skin tumors, including periungual (Koenen) and subungual fibromas
• Superficial pigmented lesions
• Aden sebaceous hypertrophy or sebaceous hyperplasia
• Rhinophyma reduction
• Cutaneous papilloma (skin tags)
• Milia
• Debridement of eczematous or infected skin
• Basal and squamous cell carcinoma, including keratoacanthomas, Bowen's disease (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions
• Nevi, including spider, epidermal and protruding
• Neurofibromas
• Laser de-epithelialization
• Trichoepitheliomas
• Xanthelasma Palpebrarum
• Syringoma

Laser ablation, vaporization and /or excision for complete or partial nail matrixectomy.

Vaporization/coagulation of:

• Benign/malignant vascular/avascular skin lesions
• Moh's Surgery
• Lipectomy
• Verrucae and seborrheic vulgaris, including paronychial, perifungal, and subungual warts

Laser incision and /or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty.

Laser incision and /or excision of soft tissue for the creation of recipient sites for hair transplantation.

Podiatry

Laser ablation, vaporization and /or excision of soft tissue for the reduction, removal, and/or treatment of:

• Verrucae vulgaris/plantar (warts), including paronychial, perifungal, and subungual warts
• Fungal nail treatment
• Porokeratoma ablation
• Ingrown nail treatment
• Neuromas/fibromas, including Morton's neuroma
• Debridement of ulcers
• Other soft tissue lesions

Laser ablation, vaporization and /or excision in podiatry for complete or partial matrixectomy.

Page 12

Otolaryngology (ENT)

Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology the treatment of:

• Choanal atresia
• Leukoplakia, including oral, larynx, uvula, palatal, upper lateral pharyngeal tissue
• Nasal obstruction
• Adult and juvenile papillomatosis polyps
• Polypectomy of nose and nasal passages
• Lymphangioma removal
• Removal of vocal cord/fold nodules, polyps and cysts
• Removal of recurrent papillomas in the oral cavity, nasal cavity, larynx, pharynx and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tongue and vocal cords
• Laser/tumor surgery in the larynx, pharynx, nasal, ear and oral structure and tissue
• Zenker's Diverticulum/pharyngoesophageal diverticulum [endoscopic laser-assisted esophageal diverticulectomy (ELAED)]
• Stenosis, including subglottic stenosis; tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil ablation/tonsillotomy
• Pulmonary bronchial and tracheal lesion removal
• Benign and malignant nodules, tumors and fibromas (larynx, pharynx, trachea, tracheobronchial/endobronchial)
• Benign and malignant lesions and fibromas (nose and nasal passages)
• Benign and malignant tumors and fibromas; (oral)
• Stapedotomy/stapedectomy
• Acoustic neuroma in the ear
• Superficial lesions of the ear, including chondrodermatitis nondularis chronica helices/Winkler's disease
• Telangiectasia/hemangioma of larynx, pharynx and trachea (includes uvula, palatal or upper lateral pharyngeal tissue)
• Cordectomy, cordotomy (for the treatment of vocal fold paralysis/vocal fold motion impairment), and cordal lesions of larynx, pharynx and trachea
• Myringotomy/tympanostomy (tympanic membrane fenestration)
• Uvulopalatoplasty (LAUP, laser UPPP)
• Turbinectomy and turbinate reduction/ablation)
• Septal spur ablation/reduction and septoplasty
• Partial glossectomy
• Tumor resection on oral, subfascial and neck tissues
• Rhinophyma
• Verrucae vulgaris (warts)
• Gingivoplasty/gingivectomy

Gynecology (GYN)

Laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for the treatment of:

• Conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia (VIN, VAIN)
• Condyloma acuminate, including cervical, genital, vulvar, perineal, and Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosis (BP) lesions
• Leukoplakia (vulvar dystrophies)
• Incision and drainage (I&D) of Bartholin's and Nabothian cysts

Page 13

• Herpes vaporization
• Urethral caruncle vaporization
• Cervical dysplasia
• Benign and malignant tumors
• Hemangiomas

GYN Laparoscopy

Vaporization, incision, excision, ablation, or photocoagulation of soft tissue in endoscopic and laparoscopic surgery, including GYN laparoscopy, for treatment of:

• Endometrial lesions, including ablation of endometriosis
• Excision/lysis of adhesions
• Salpingostomy
• Oophorectomy/ovariectomy
• Fimbrioplasty
• Metroplasty
• Microsurgery (tubal)
• Uterine myomas and fibroids
• Ovarian fibromas and follicle cysts
• Uterosacral ligament ablation
• Hysterectomy

Neurosurgery

Laser incision, excision, ablation and/or vaporization and of soft tissue in neurosurgery for the treatment of:

Cranial

• Posterior fossa tumors
• Peripheral neurectomy
• Benign and malignant tumors and cysts (e.g. gliomas, meningiomas (including basal tumors), acoustic neuromas, lipomas and large tumors)
• Arteriovenous malformation
• Pituitary gland tumors (transsphenoidal approach)

Spinal Cord

• Incision/excision and vaporization of benign and malignant tumors and cysts
• Intra- and extradural lesions
• Laminectomy/ laminotomy/ microdiscectomy

Orthopedics

Incision/excision and vaporization and of soft tissue in orthopedic surgery. Applications include:

Arthroscopy

• Meniscectomy
• Chondromalacia
• Chondroplasty
• Ligament release (lateral and other)
• Excision of plica
• Partial synovectomy

General

• Debridement of traumatic wounds
• Debridement of decubitus and diabetic ulcers

Page 14

• Microsurgery
• Artificial joint revision
• PMMA removal

General/Thoracic Surgery

Incision, excision and vaporization and of soft tissue in general and thoracic surgery including endoscopic and open procedures. Applications include:

• Debridement of decubitus ulcers, stasis, diabetic and other ulcers
• Mastectomy
• Debridement of burns
• Rectal and anal hemorrhoidectomy
• Breast biopsy
• Reduction mammoplasty
• Cytoreduction for metastatic disease
• Laparotomy and laparoscopic applications
• Mediastinal and thoracic lesions and abnormalities
• Skin tag vaporization
• Atheroma
• Cysts, including sebaceous cysts, pilar cysts, and mucous cysts of the lips
• Pilonidal cyst removal and repair
• Abscesses
• Other soft tissue applications

Dental/Oral Surgery

Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include:

• Gingivectomy- removal of hyperplasia
• Gingivoplasty
• Incisional and excisional biopsy
• Treatment of ulcerous lesions, including aphthous ulcers
• Incision of infection when used with antibiotic therapy
• Frenectomy (frenum release)
• Excision and ablation of benign and malignant lesions
• Homeostasis
• Operculectomy
• Crown lengthening
• Removal of soft tissue, cysts and tumors
• Oral cavity tumors and hemangiomas
• Abscesses
• Extraction site hemostasis
• Salivary gland pathologies
• Pre-prosthetic gum preparation
• Leukoplakia
• Partial glossectomy
• Periodontal gum resection

Genitourinary

Incision/excision and vaporization and of soft tissue in genitourinary procedures. Applications include:

• Benign and malignant lesions of external genitalia
• Condyloma

Page 15

• Phimosis
• Erythroplasia

ProScan

The Alma Hybrid ProScan CO2 fractional applicator, with wavelength of 10600 nm is indicated for:
Laser skin resurfacing (ablation and/or vaporization) of soft tissue.

The Alma Hybrid ProScan 1570nm fractional applicator, with wavelength of 1570 nm, is indicated for: Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue

The Alma Hybrid ProScan CO2 &1570nm fractional applicator, with wavelengths of 10600 nm & 1570nm is indicated for laser skin resurfacing (ablation and/or vaporization) of soft tissue.

Page 16

VI. Summary of technological characteristics of the device compared to the predicates [21 CFR 807.92(a)(6)]

Parameter	Subject Device	Primary Predicate	Reference Predicate	Similarities / Differences
Hybrid-Hylight Applicator	Hybrid-Hylight Applicator	K203441	Alma Pixel CO2 (K103501)
Wavelength	10600 nm	10600 nm	10600 nm	Same
Pilot beam	650 nm, 3mW	650 nm, 3mW	650 nm, <5 mW	Same
Operation Mode	Repeat pulse/CW	Repeat pulse/CW	Repeat/Super Pulse/CW	Same
Spot size (mm)	0.15 – 3.1 mm	0.15- 3.1 mm	0.125 mm dia spot at tip of spatula at 50 mm working distance 0.2mm dia. Spot at tip of spatula at 100 mm working distance	Same
Repetition Rate	1-5 Hz	1-5 Hz	CW 1-5 Hz	Same
Pulse Duration	10-1000 ms	10-1000 ms	10-1000 ms for CW	Same
Repeat Delay	CW On time: 10 - 1000 msec(0.01 – 1sec) NA	CW On time: 10 - 1000 msec(0.01 – 1sec) NA	CW On time: 10 - 1000 msec (0.01 – 1 sec)	Same
Min output energy	5 mJ	5 mJ	1 mJ	Same
Fluence	Max 1746 J/mm2 for 30W system Max 3530 J/mm2 for the 70W system	Max 1746 J/mm2 for 30W system Max 3530 J/mm2 for the 70W system	Max 1746 J/mm2 for 30W system Max 3530 J/mm2 for the 70W system	Same

Page 17

Parameter	Subject Device	Primary Predicate	Reference Predicate	Similarities / Differences
Hybrid-Hylight Applicator	Hybrid-Hylight Applicator K203441	Alma Pixel CO2 (K103501)
Wavelength	10600 nm	10600 nm	10600 nm	Same
Pilot beam	650 nm, 3mW	650 nm, 3mW	650 nm, <5 mW	Same
Operation Mode	Repeat pulse/CW	Repeat pulse/CW	Repeat/Super Pulse/CW	Same –
Spot size (mm)	0.15 – 3.1 mm	0.15- 3.1 mm	0.125 mm dia spot at tip of spatula at 50 mm working distance 0.2mm dia. Spot at tip of spatula at 100 mm working distance	Same
Repetition Rate	1-5 Hz	1-5 Hz	CW 1-5 Hz	Same
Pulse Duration	10-1000 ms	10-1000 ms	10-1000 ms for CW	Same
Repeat Delay	CW On time: 10 - 1000 msec (0.01 – 1 sec) NA	CW On time: 10 - 1000 msec (0.01 – 1 sec) NA	CW On time: 10 - 1000 msec (0.01 – 1 sec)	Same
Min output energy	5 mJ	5 mJ	1 mJ	Same
Fluence	Max 1746 J/mm2 for 30W system Max 3530 J/mm2 for the 70W system	Max 1746 J/mm2 for 30W system Max 3530 J/mm2 for the 70W system	Max 1746 J/mm2 for 30W system Max 3530 J/mm2 for the 70W system	Same

Page 18

Parameter	Subject Device	Primary Predicate	Reference Predicate	Similarities / Differences
Pixel Applicator
Spot size (mm)	0.125 to 0.20 mm dia. pixels in a 10 x10 mm2 area (49 pixels) @ 50 mm distance – 0.125 to 0.20 mm dia. pixels in a 11 x 11 mm2 area (81 pixels) @ 100 mm distance	0.125 to 0.20 mm dia. pixels in a 10 x10 mm2 area (49 pixels) @ 50 mm distance – 0.125 to 0.20 mm dia. pixels in a 11 x 11 mm2 area (81 pixels) @ 100 mm distance	0.125 to 0.20 mm dia. pixels in a 10 x10 mm2 area (49 pixels) @ 50 mm distance – 0.125 to 0.20 mm dia. pixels in a 11 x 11 mm2 area (81 pixels) @ 100 mm distance	Same
Repetition Rate	0.5-2Hz	0.5-2Hz	1-5 Hz	Same
Pulse Duration	1- 405 ms	1- 405 ms	100-300 ms for pulsed	Same
Min output energy	5 mJ/pixel	5 mJ/pixel	Up to 1000 mJ	Same
Max output energy	SW limited to 150 mJ/pixel	SW limited to 150 mJ/pixel	Up to 1000 mJ SW limited to 150	Same
Output Power	30 W, 70W	30 W, 70W	30 W, 70W	Same
1570nm For ProScan Applicator
Wavelength	1570nm	1570nm	N/A	Same as Primary Predicate
Scan size (mm)	Up to 30mm diameter	Up to 30mm diameter	N/A	Same as Primary Predicate
Output energy	24mJ-144mJ/pixel	24mJ-144mJ/pixel	N/A	Same as Primary Predicate

Page 19

Parameter	Subject Device	Primary Predicate	Reference Predicate	Similarities / Differences
Spot size (mm)
Pixel Applicator	0.125 to 0.20 mm dia. pixels in a 10 x10 mm2 area (49 pixels) @ 50 mm distance – 0.125 to 0.20 mm dia. pixels in a 11 x 11 mm2 area (81 pixels) @ 100 mm distance	0.125 to 0.20 mm dia. pixels in a 10 x10 mm2 area (49 pixels) @ 50 mm distance – 0.125 to 0.20 mm dia. pixels in a 11 x 11 mm2 area (81 pixels) @ 100 mm distance	0.125 to 0.20 mm dia. pixels in a 10 x10 mm2 area (49 pixels) @ 50 mm distance – 0.125 to 0.20 mm dia. pixels in a 11 x 11 mm2 area (81 pixels) @ 100 mm distance	Same
Repetition Rate	0.5-2Hz	0.5-2Hz	1-5 Hz	Same
Pulse Duration	1- 405 ms	1- 405 ms	100-300 ms for pulsed	Same
Min output energy	5 mJ/pixel	5 mJ/pixel	Up to 1000 mJ	Same
Max output energy	SW limited to 150 mJ/pixel	SW limited to 150 mJ/pixel	Up to 1000 mJ SW limited to 150	Same
Output Power	30 W, 70W	30 W, 70W	30 W, 70W	Same
Wavelength	1570nm- For ProScan Applicator	1570nm- For ProScan Applicator	N/A	Same as Primary Predicate
Scan size (mm)	Up to 30mm diameter	Up to 30mm diameter	N/A	Same as Primary Predicate
Output energy	24mJ-144mJ/pixel	24mJ-144mJ/pixel	N/A	Same as Primary Predicate

Page 20

Parameter	Subject Device	Primary Predicate	Reference Predicate	Similarities / Differences
Indications for Use	The Alma Hybrid Laser System (Pixel and HyLight CO2 Applicators) is intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery), podiatry, gynecology, neurosurgery, orthopedics (soft tissue), arthroscopy (knee).The Alma Hybrid Laser System is cleared for use for the particular indications as follows: Dermatology & Plastic Surgery The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of: • Laser skin resurfacing • Laser dermabrasion	The Alma Hybrid Laser System and Accessories are intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery). HyLight-CO2 The Alma Hybrid CO2 non-fractional applicator, with wavelength of 10600 nm is cleared for use for the particular indications as follows: Dermatology & Plastic Surgery The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of: * laser skin resurfacing* laser derm-abrasion* laser burn debridement.Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: warts, acne scars, nevi epidermal, syringoma. Vaporization/coagulation of warts.	The Alma Pixel CO2 Laser System is intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery), podiatry, gynecology, neurosurgery, orthopedics (soft tissue), arthroscopy (knee).The Alma Hybrid Laser System is cleared for use for the particular indications as follows: Dermatology & Plastic Surgery The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of: • Laser skin resurfacing	Same as the Reference Predicate

Page 21

Parameter	Subject Device	Primary Predicate	Reference Predicate	Similarities / Differences
Indications for Use	The Alma Hybrid Laser System (Pixel and HyLight CO2 Applicators) is intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery), podiatry, gynecology, neurosurgery, orthopedics (soft tissue), arthroscopy (knee).The Alma Hybrid Laser System is cleared for use for the particular indications as follows: Dermatology & Plastic Surgery The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of: • Laser skin resurfacing • Laser dermabrasion	The Alma Hybrid Laser System and Accessories are intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery). HyLight-CO2 The Alma Hybrid CO2 non-fractional applicator, with wavelength of 10600 nm is cleared for use for the particular indications as follows: Dermatology & Plastic Surgery The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of: * laser skin resurfacing* laser derm-abrasion* laser burn debridement.Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: warts, acne scars, nevi epidermal, syringoma. Vaporization/coagulation of warts.	The Alma Pixel CO2 Laser System is intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery), podiatry, gynecology, neurosurgery, orthopedics (soft tissue), arthroscopy (knee).The Alma Hybrid Laser System is cleared for use for the particular indications as follows: Dermatology & Plastic Surgery The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of: • Laser skin resurfacing	Same as the Reference Predicate

Page 22

Parameter	Subject Device	Primary Predicate	Reference Predicate	Similarities / Differences
	• Laser burn debridement. Laser skin resurfacing (ablation and/or vaporization) for the treatment of: • Wrinkles, rhytids, and furrows (including fines lines and texture irregularities) Clinical literature demonstrates that skin resurfacing of wrinkles, rhytids, and furrows with CO2 laser increases the amount of sub-epidermal collagen. Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: • Keratoses, including actinic and seborrheic keratosis, seborrheic vulgaris,	• Laser dermabrasion • Laser burn debridement. Laser skin resurfacing (ablation and/or vaporization) for the treatment of: • Wrinkles, rhytids, and furrows (including fines lines and texture irregularities) Clinical literature demonstrates that skin resurfacing of wrinkles, rhytids, and furrows with CO2 laser increases the amount of sub-epidermal collagen. Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: • Keratoses, including actinic	Pixel The Alma Hybrid Pixel CO2 fractional applicator, with wavelength 10600 nm is indicated for: The ablation, vaporization, and coagulation of soft tissue in dermatology and plastic surgery in the performance of skin resurfacing. ProScan The Alma Hybrid ProScan CO2 fractional applicator, with wavelength of 10600 nm is indicated for: •Laser skin resurfacing (ablation and/or vaporization) of soft tissue The Alma Hybrid ProScan 1570nm fractional applicator, with wavelength of 1570 nm, is indicated for: •Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue The Alma Hybrid ProScan CO2 &1570nm fractional applicator, with wavelengths of 10600 nm & 1570nm is indicated for laser skin resurfacing (ablation and/or vaporization) of soft tissue.

Page 23

Parameter	Subject Device	Primary Predicate	Reference Predicate	Similarities / Differences
	• Laser burn debridement. Laser skin resurfacing (ablation and/or vaporization) for the treatment of: • Wrinkles, rhytids, and furrows (including fines lines and texture irregularities) Clinical literature demonstrates that skin resurfacing of wrinkles, rhytids, and furrows with CO2 laser increases the amount of sub-epidermal collagen. Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: • Keratoses, including actinic and seborrheic keratosis, seborrheic vulgaris, seborrheic wart, and verruca seborrhoica;	Pixel The Alma Hybrid Pixel CO2 fractional applicator, with wavelength 10600 nm is indicated for: The ablation, vaporization, and coagulation of soft tissue in dermatology and plastic surgery in the performance of skin resurfacing. ProScan The Alma Hybrid ProScan CO2 fractional applicator, with wavelength of 10600 nm is indicated for: •Laser skin resurfacing (ablation and/or vaporization) of soft tissue The Alma Hybrid ProScan 1570nm fractional applicator, with wavelength of 1570 nm, is indicated for: •Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue The Alma Hybrid ProScan CO2 &1570nm fractional applicator, with wavelengths of 10600 nm & 1570nm is indicated for laser skin resurfacing (ablation and/or vaporization) of soft tissue.	• Laser dermabrasion • Laser burn debridement. Laser skin resurfacing (ablation and/or vaporization) for the treatment of: • Wrinkles, rhytids, and furrows (including fines lines and texture irregularities) Clinical literature demonstrates that skin resurfacing of wrinkles, rhytids, and furrows with CO2 laser increases the amount of sub-epidermal collagen. Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: • Keratoses, including actinic

Page 24

Parameter	Subject Device	Primary Predicate	Reference Predicate	Similarities / Differences
	seborrheic wart, and verruca seborrhoica; • Vermilionectomy of the lip; • Cutaneous horns; • Solar/actinic elastosis; • Cheilitis, including actinic cheilitis; • Lentigines, including lentigo maligna or Hutchinson's malignant freckle; • Uneven pigmentation/ dyschromia; • Acne scars; • Surgical scars; • Keloids including acne keloidalis nuchae; • Hemangiomas (including Buccal, port wine and pyogenic granulomas/granuloma	and seborrheic keratosis, seborrheic vulgaris, seborrheic wart, and verruca seborrhoica; • Vermilionectomy of the lip; • Cutaneous horns; • Solar/actinic elastosis; • Cheilitis, including actinic cheilitis; • Lentigines, including lentigo maligna or Hutchinson's malignant freckle; • Uneven pigmentation/ dyschromia; • Acne scars; • Surgical scars; • Keloids including acne	and seborrheic keratosis, seborrheic vulgaris, seborrheic wart, and verruca seborrhoica; • Vermilionectom y of the lip; • Cutaneous horns; • Solar/actinic elastosis; • Cheilitis, including actinic cheilitis; • Lentigines, including lentigo maligna or Hutchinson's malignant freckle; • Uneven pigmentation/ dyschromia; • Acne scars; • Surgical scars; • Keloids including acne

Page 25

Parameter	Subject Device	Primary Predicate	Reference Predicate	Similarities / Differences
	pyogenicum/granuloma telagiectaticum); • Tattoos; • Telangiectasia; • Removal of small skin tumors, including periungual (Koenen) and subungual fibromas; • Superficial pigmented lesions; • Aden sebaceous hypertrophy or sebaceous hyperplasia; • Rhinophyma reduction; • Cutaneous papilloma (skin tags); • Milia; • Debridement of eczematous or infected skin; • Basal and squamous cell carcinoma,	keloidalis nuchae; • Hemangiomas (including Buccal, port wine and pyogenic granulomas/granuloma pyogenicum/granuloma telagiectaticum); • Tattoos; • Telangiectasia; • Removal of small skin tumors, including periungual (Koenen) and subungual fibromas; • Superficial pigmented lesions; • Aden sebaceous hypertrophy or sebaceous hyperplasia;	keloidalis nuchae; • Hemangiomas (including Buccal, port wine and pyogenic granulomas/gran uloma pyogenicum/gra nuloma telagiectaticum); • Tattoos; • Telangiectasia; • Removal of small skin tumors, including periungual (Koenen) and subungual fibromas; • Superficial pigmented lesions; • Aden sebaceous hypertrophy or sebaceous hyperplasia;

Page 26

Parameter	Subject Device	Primary Predicate	Reference Predicate	Similarities / Differences
	including keratoacanthomas, Bowen's disease (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions; • Nevi, including spider, epidermal and protruding; • Neurofibromas; • Laser de-epithelialization; • Trichoepitheliomas; • Xanthelasma Palpebrarum; • Syringoma Laser ablation, vaporization and /or excision for complete or partial nail matrixectomy. Vaporization/coagulation of: • Benign/malignant vascular/avascular skin lesions; • Moh's Surgery; • Lipectomy;	• Rhinophyma reduction; • Cutaneous papilloma (skin tags); • Milia; • Debridement of eczematous or infected skin; • Basal and squamous cell carcinoma, including keratoacanthomas, Bowen's disease (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions; • Nevi, including spider, epidermal and protruding; • Neurofibromas; • Laser de-epithelialization; • Trichoepitheliomas;	• Rhinophyma reduction; • Cutaneous papilloma (skin tags); • Milia; • Debridement of eczematous or infected skin; • Basal and squamous cell carcinoma, including keratoacanthoma s, Bowen's disease (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions; • Nevi, including spider, epidermal and protruding; • Neurofibromas; • Laser de-epithelialization; • Trichoepithelio mas;

Page 27

Parameter	Subject Device	Primary Predicate	Reference Predicate	Similarities / Differences
	• Verrucae and seborrheic vulgaris, including paronychial, perifungal, and subungual warts. Laser incision and /or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty. Laser incision and /or excision of soft tissue for the creation of recipient sites for hair transplantation. Laser incision and /or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty. Laser incision and /or excision of soft tissue for the creation of recipient sites for hair transplantation. Podiatry Laser ablation, vaporization and /or excision of soft tissue for	• Xanthelasma Palpebrarum; • Syringoma Laser ablation, vaporization and /or excision for complete or partial nail matrixectomy. Vaporization/coagulation of: • Benign/maligna nt vascular/avascular skin lesions; • Moh's Surgery; • Lipectomy; • Verrucae and seborrheic vulgaris, including paronychial, perifungal, and subungual warts. Laser incision and /or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty. Laser incision and /or	• Xanthelasma Palpebrarum; • Syringoma Laser ablation, vaporization and /or excision for complete or partial nail matrixectomy. Vaporization/coagulatio n of: • Benign/maligna nt vascular/avascul ar skin lesions; • Moh's Surgery; • Lipectomy; • Verrucae and seborrheic vulgaris, including paronychial, perifungal, and subungual warts. Laser incision and /or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty. Laser incision and /or

Page 28

Parameter	Subject Device	Primary Predicate	Reference Predicate	Similarities / Differences
	the reduction, removal, and/or treatment of: • Verrucae vulgaris/plantar (warts), including paronychial, perifungal, and subungual warts; • Fungal nail treatment; • Porokeratoma ablation; • Ingrown nail treatment; • Neuromas/fibromas, including Morton's neuroma; • Debridement of ulcers; • Other soft tissue lesions. Laser ablation, vaporization and /or excision in podiatry for complete or partial matrixectomy. Otolaryngology (ENT)	excision of soft tissue for the creation of recipient sites for hair transplantation. Laser incision and /or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty. Laser incision and /or excision of soft tissue for the creation of recipient sites for hair transplantation. Podiatry Laser ablation, vaporization and /or excision of soft tissue for the reduction, removal, and/or treatment of: • Verrucae vulgaris/plantar (warts), including paronychial, perifungal, and subungual warts; • Fungal nail treatment; • Porokeratoma ablation;	excision of soft tissue for the creation of recipient sites for hair transplantation. Laser incision and /or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty. Laser incision and /or excision of soft tissue for the creation of recipient sites for hair transplantation. Podiatry Laser ablation, vaporization and /or excision of soft tissue for the reduction, removal, and/or treatment of: • Verrucae vulgaris/plantar (warts), including paronychial, perifungal, and subungual warts; • Fungal nail treatment; • Porokeratoma ablation;

Page 29

Parameter	Subject Device	Primary Predicate	Reference Predicate	Similarities / Differences
Otolaryngology (ENT)	Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology the treatment of: • Choanal atresia, • Leukoplakia, including oral, larynx, uvula, palatal, upper lateral pharyngeal tissue; • Nasal obstruction; • Adult and juvenile papillomatosis polyps; • Polypectomy of nose and nasal passages; • Lymphangioma removal; • Removal of vocal cord/fold nodules, polyps and cysts; • Removal of recurrent papillomas in the oral cavity, nasal cavity, larynx, pharynx and trachea, including	• Ingrown nail treatment; • Neuromas/fibro mas, including Morton's neuroma; • Debridement of ulcers; • Other soft tissue lesions. Laser ablation, vaporization and /or excision in podiatry for complete or partial matrixectomy. Otolaryngology (ENT) Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology the treatment of: • Choanal atresia, • Leukoplakia, including oral, larynx, uvula, palatal, upper lateral	• Ingrown nail treatment; • Neuromas/fibro mas, including Morton's neuroma; • Debridement of ulcers; • Other soft tissue lesions. Laser ablation, vaporization and /or excision in podiatry for complete or partial matrixectomy. Otolaryngology (ENT) Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology the treatment of: • Choanal atresia, • Leukoplakia, including oral, larynx, uvula, palatal, upper lateral

Page 30

Parameter	Subject Device	Primary Predicate	Reference Predicate	Similarities / Differences
	the uvula, palatal, upper lateral pharyngeal tissue, tongue and vocal cords; • Laser/tumor surgery in the larynx, pharynx, nasal, ear and oral structure and tissue • Zenker's Diverticulum/pharyngoesophageal diverticulum [endoscopic laser-assisted esophageal diverticulectomy (ELAED)]; • Stenosis, including subglottic stenosis; tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil	pharyngeal tissue; • Nasal obstruction; • Adult and juvenile papillomatosis polyps; • Polypectomy of nose and nasal passages; • Lymphangioma removal; • Removal of vocal cord/fold nodules, polyps and cysts; • Removal of recurrent papillomas in the oral cavity, nasal cavity, larynx, pharynx and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tongue and vocal cords;	pharyngeal tissue; • Nasal obstruction; • Adult and juvenile papillomatosis polyps; • Polypectomy of nose and nasal passages; • Lymphangioma removal; • Removal of vocal cord/fold nodules, polyps and cysts; • Removal of recurrent papillomas in the oral cavity, nasal cavity, larynx, pharynx and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tongue and vocal cords;

Page 31

Parameter	Subject Device	Primary Predicate	Reference Predicate	Similarities / Differences
	ablation/tonsilloto my; • Pulmonary bronchial and tracheal lesion removal; • Benign and malignant nodules, tumors and fibromas (larynx, pharynx, trachea, tracheobronchial/e ndobronchial); • Benign and malignant lesions and fibromas (nose and nasal passages); • Benign and malignant tumors and fibromas; (oral); • Stapedotomy/stap edectomy; • Acoustic neuroma in the ear; • Superficial lesions of the ear, including	• Laser/tumor surgery in the larynx, pharynx, nasal, ear and oral structure and tissue • Zenker's Diverticulum/pharyngoesophageal diverticulum [endoscopic laser-assisted esophageal diverticulectomy (ELAED)]; • Stenosis, including subglottic stenosis; tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil ablation/tonsillotomy; • Pulmonary bronchial and	• Laser/tumor surgery in the larynx, pharynx, nasal, ear and oral structure and tissue • Zenker's Diverticulum/ph aryngoesophage al diverticulum [endoscopic laser-assisted esophageal diverticulectomy (ELAED)]; • Stenosis, including subglottic stenosis; tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil ablation/tonsillot omy; • Pulmonary bronchial and

Page 32

Parameter	Subject Device	Primary Predicate	Reference Predicate	Similarities / Differences
	chondrodermatitis nondularis chronica helices/Winkler's disease; • Telangiectasia/he mangioma of larynx, pharynx and trachea (includes uvula, palatal or upper lateral pharyngeal tissue); • Cordectomy, cordotomy (for the treatment of vocal fold paralysis/vocal fold motion impairment), and cordal lesions of larynx, pharynx and trachea; • Myringotomy/tym panostomy (tympanic membrane fenestration);	tracheal lesion removal; • Benign and malignant nodules, tumors and fibromas (larynx, pharynx, trachea, tracheobronchial/endobronchial); • Benign and malignant lesions and fibromas (nose and nasal passages); • Benign and malignant tumors and fibromas; (oral); • Stapedotomy/sta pedectomy; • Acoustic neuroma in the ear; • Superficial lesions of the ear, including chondrodermatit	tracheal lesion removal; • Benign and malignant nodules, tumors and fibromas (larynx, pharynx, trachea, tracheobronchial /endobronchial); • Benign and malignant lesions and fibromas (nose and nasal passages); • Benign and malignant tumors and fibromas; (oral); • Stapedotomy/sta pedectomy; • Acoustic neuroma in the ear; • Superficial lesions of the ear, including chondrodermatit

Page 33

Parameter	Subject Device	Primary Predicate	Reference Predicate	Similarities / Differences
	• Uvulopalatoplasty (LAUP, laser UPPP); • Turbinectomy and turbinate reduction/ablation); • Septal spur ablation/reduction and septoplasty; • Partial glossectomy; • Tumor resection on oral, subfascial and neck tissues; • Rhinophyma; • Verrucae vulgaris (warts); • Gingivoplasty/gin givectomy. Gynecology (GYN) Laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for the treatment of: • Conization of the cervix, including cervical	is nondularis chronica helices/Winkler's disease; • Telangiectasia/h emangioma of larynx, pharynx and trachea (includes uvula, palatal or upper lateral pharyngeal tissue); • Cordectomy, cordotomy (for the treatment of vocal fold paralysis/vocal fold motion impairment), and cordal lesions of larynx, pharynx and trachea; • Myringotomy/ty mpanostomy (tympanic membrane fenestration);	is nondularis chronica helices/Winkler' s disease; • Telangiectasia/h emangioma of larynx, pharynx and trachea (includes uvula, palatal or upper lateral pharyngeal tissue); • Cordectomy, cordotomy (for the treatment of vocal fold paralysis/vocal fold motion impairment), and cordal lesions of larynx, pharynx and trachea; • Myringotomy/ty mpanostomy (tympanic membrane fenestration);

Page 34

Parameter	Subject Device	Primary Predicate	Reference Predicate	Similarities / Differences
	intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia (VIN, VAIN); • Condyloma acuminate, including cervical, genital, vulvar, perineal, and Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosis (BP) lesions; • Leukoplakia (vulvar dystrophies); • Incision and drainage (I&D) of Bartholin's and Nabothian cysts; • Herpes vaporization; • Urethral caruncle vaporization; • Cervical dysplasia;	• Uvulopalatoplast y (LAUP, laser UPPP); • Turbinectomy and turbinate reduction/ablation ); • Septal spur ablation/reduction and septoplasty; • Partial glossectomy; • Tumor resection on oral, subfascial and neck tissues; • Rhinophyma; • Verrucae vulgaris (warts); • Gingivoplasty/gin givectomy. Gynecology (GYN) Laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for the treatment of:	• Uvulopalatoplast y (LAUP, laser UPPP); • Turbinectomy and turbinate reduction/ablatio n); • Septal spur ablation/reductio n and septoplasty; • Partial glossectomy; • Tumor resection on oral, subfascial and neck tissues; • Rhinophyma; • Verrucae vulgaris (warts); • Gingivoplasty/gi ngivectomy. Gynecology (GYN) Laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for the treatment of:

Page 35

Parameter	Subject Device	Primary Predicate	Reference Predicate	Similarities / Differences
	• Benign and malignant tumors; • Hemangiomas. GYN Laparoscopy Vaporization, incision, excision, ablation, or photocoagulation of soft tissue in endoscopic and laparoscopic surgery, including GYN laparoscopy, for treatment of: • Endometrial lesions, including ablation of endometriosis; • Excision/lysis of adhesions; • Salpingostomy • Oophorectomy/ov ariectomy; • Fimbrioplasty; • Metroplasty; • Microsurgery (tubal); • Uterine myomas and fibroids; • Ovarian fibromas and follicle cysts;	• Conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia (VIN, VAIN); • Condyloma acuminate, including cervical, genital, vulvar, perineal, and Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosis (BP) lesions; • Leukoplakia (vulvar dystrophies); • Incision and drainage (I&D) of Bartholin's	• Conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia (VIN, VAIN); • Condyloma acuminate, including cervical, genital, vulvar, perineal, and Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosis (BP) lesions; • Leukoplakia (vulvar dystrophies); • Incision and drainage (I&D) of Bartholin's

Page 36

Parameter	Subject Device	Primary Predicate	Reference Predicate	Similarities / Differences
	• Uterosacral ligament ablation; • Hysterectomy. Neurosurgery Laser incision, excision, ablation and/or vaporization and of soft tissue in neurosurgery for the treatment of: Cranial • Posterior fossa tumors; • Peripheral neurectomy; • Benign and malignant tumors and cysts (e.g. gliomas, meningiomas (including basal tumors), acoustic neuromas, lipomas and large tumors); • Arteriovenous malformation; • Pituitary gland tumors (transsphenoidal approach).	and Nabothian cysts; • Herpes vaporization; • Urethral caruncle vaporization; • Cervical dysplasia; • Benign and malignant tumors; • Hemangiomas. GYN Laparoscopy Vaporization, incision, excision, ablation, or photocoagulation of soft tissue in endoscopic and laparoscopic surgery, including GYN laparoscopy, for treatment of: • Endometrial lesions, including ablation of endometriosis; • Excision/lysis of adhesions; • Salpingostomy	and Nabothian cysts; • Herpes vaporization; • Urethral caruncle vaporization; • Cervical dysplasia; • Benign and malignant tumors; • Hemangiomas GYN Laparoscopy Vaporization, incision, excision, ablation, or photocoagulation of soft tissue in endoscopic and laparoscopic surgery, including GYN laparoscopy, for treatment of: • Endometrial lesions, including ablation of endometriosis; • Excision/lysis of adhesions; • Salpingostomy

Page 37

Parameter	Subject Device	Primary Predicate	Reference Predicate	Similarities / Differences
Spinal Cord	• Incision/excision and vaporization of benign and malignant tumors and cysts; • Intra- and extradural lesions; • Laminectomy/ laminotomy/ microdiscectomy. Orthopedics Incision/excision and vaporization and of soft tissue in orthopedic surgery. Applications include: Arthroscopy • Meniscectomy; • Chondromalacia; • Chondroplasty; • Ligament release (lateral and other); • Excision of plica; • Partial synovectomy. General • Debridement of traumatic wounds;	• Oophorectomy/o variectomy; • Fimbrioplasty; • Metroplasty; • Microsurgery (tubal); • Uterine myomas and fibroids; • Ovarian fibromas and follicle cysts; • Uterosacral ligament ablation; • Hysterectomy. Neurosurgery Laser incision, excision, ablation and/or vaporization and of soft tissue in neurosurgery for the treatment of: Cranial • Posterior fossa tumors; • Peripheral neurectomy; • Benign and malignant tumors and cysts (e.g. gliomas,	• Oophorectomy/o variectomy; • Fimbrioplasty; • Metroplasty; • Microsurgery (tubal); • Uterine myomas and fibroids; • Ovarian fibromas and follicle cysts; • Uterosacral ligament ablation; • Hysterectomy. Neurosurgery Laser incision, excision, ablation and/or vaporization and of soft tissue in neurosurgery for the treatment of: Cranial • Posterior fossa tumors; • Peripheral neurectomy; • Benign and malignant tumors and cysts (e.g. gliomas,

Page 38

Parameter	Subject Device	Primary Predicate	Reference Predicate	Similarities / Differences
	• Debridement of decubitus and diabetic ulcers; • Microsurgery; • Artificial joint revision; • PMMA removal. General/Thoracic Surgery Incision, excision and vaporization and of soft tissue in general and thoracic surgery including endoscopic and open procedures. Applications include: • Debridement of decubitus ulcers, stasis, diabetic and other ulcers; • Mastectomy; • Debridement of burns; • Rectal and anal hemorrhoidectomy; • Breast biopsy; • Reduction mammoplasty;	meningiomas (including basal tumors), acoustic neuromas, lipomas and large tumors); • Arteriovenous malformation; • Pituitary gland tumors (transsphenoidal approach). Spinal Cord • Incision/excision and vaporization of benign and malignant tumors and cysts; • Intra- and extradural lesions; • Laminectomy/ laminotomy/ microdiscectomy. Orthopedics Incision/excision and	meningiomas (including basal tumors), acoustic neuromas, lipomas and large tumors); • Arteriovenous malformation; • Pituitary gland tumors (transsphenoidal approach). Spinal Cord • Incision/excision and vaporization of benign and malignant tumors and cysts; • Intra- and extradural lesions; • Laminectomy/ laminotomy/ microdiscectom y. Orthopedics Incision/excision and

Page 39

Parameter	Subject Device	Primary Predicate	Reference Predicate	Similarities / Differences
	• Cytoreduction for metastatic disease; • Laparotomy and laparoscopic applications; • Mediastinal and thoracic lesions and abnormalities; • Skin tag vaporization; • Atheroma; • Cysts, including sebaceous cysts, pilar cysts, and mucous cysts of the lips; • Pilonidal cyst removal and repair; • Abscesses; • Other soft tissue applications. Dental/Oral Surgery Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include:	vaporization and of soft tissue in orthopedic surgery. Applications include: Arthroscopy • Meniscectomy; • Chondromalacia ; • Chondroplasty; • Ligament release (lateral and other); • Excision of plica; • Partial synovectomy. General • Debridement of traumatic wounds; • Debridement of decubitus and diabetic ulcers; • Microsurgery; • Artificial joint revision; • PMMA removal. General/Thoracic Surgery	vaporization and of soft tissue in orthopedic surgery. Applications include: Arthroscopy • Meniscectomy; • Chondromalacia ; • Chondroplasty; • Ligament release (lateral and other); • Excision of plica; • Partial synovectomy. General • Debridement of traumatic wounds; • Debridement of decubitus and diabetic ulcers; • Microsurgery; • Artificial joint revision; • PMMA removal. General/Thoracic Surgery

Page 40

Parameter	Subject Device	Primary Predicate	Reference Predicate	Similarities / Differences
	• Gingivectomy- removal of hyperplasia; • Gingivoplasty; • Incisional and excisional biopsy; • Treatment of ulcerous lesions, including aphthous ulcers; • Incision of infection when used with antibiotic therapy; • Frenectomy (frenum release); • Excision and ablation of benign and malignant lesions; • Homeostasis; • Operculectomy; • Crown lengthening; • Removal of soft tissue, cysts and tumors; • Oral cavity tumors and hemangiomas; • Abscesses;	Incision, excision and vaporization and of soft tissue in general and thoracic surgery including endoscopic and open procedures. Applications include: • Debridement of decubitus ulcers, stasis, diabetic and other ulcers; • Mastectomy; • Debridement of burns; • Rectal and anal hemorrhoidecto my; • Breast biopsy; • Reduction mammoplasty; • Cytoreduction for metastatic disease; • Laparotomy and laparoscopic applications; • Mediastinal and thoracic lesions and abnormalities;	Incision, excision and vaporization and of soft tissue in general and thoracic surgery including endoscopic and open procedures. Applications include: • Debridement of decubitus ulcers, stasis, diabetic and other ulcers; • Mastectomy; • Debridement of burns; • Rectal and anal hemorrhoidecto my; • Breast biopsy; • Reduction mammoplasty; • Cytoreduction for metastatic disease; • Laparotomy and laparoscopic applications; • Mediastinal and thoracic lesions and abnormalities;

Page 41

Parameter	Subject Device	Primary Predicate	Reference Predicate	Similarities / Differences
	• Extraction site hemostasis; • Salivary gland pathologies; • Pre-prosthetic gum preparation; • Leukoplakia; • Partial glossectomy; • Periodontal gum resection. Genitourinary Incision/excision and vaporization and of soft tissue in genitourinary procedures. Applications include: • Benign and malignant lesions of external genitalia; • Condyloma; • Phimosis • Erythroplasia ProScan The Alma Hybrid ProScan CO2 fractional applicator, with wavelength of 10600 nm is indicated for: Laser skin resurfacing (ablation and/or vaporization) of soft tissue.	• Skin tag vaporization; • Atheroma; • Cysts, including sebaceous cysts, pilar cysts, and mucous cysts of the lips; • Pilonidal cyst removal and repair; • Abscesses; • Other soft tissue applications. Dental/Oral Surgery Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include: • Gingivectomy- removal of hyperplasia; • Gingivoplasty; • Incisional and excisional biopsy; • Treatment of ulcerous lesions,	• Skin tag vaporization; • Atheroma; • Cysts, including sebaceous cysts, pilar cysts, and mucous cysts of the lips; • Pilonidal cyst removal and repair; • Abscesses; • Other soft tissue applications. Dental/Oral Surgery Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include: • Gingivectomy- removal of hyperplasia; • Gingivoplasty; • Incisional and excisional biopsy; • Treatment of ulcerous lesions,

Page 42

Parameter	Subject Device	Primary Predicate	Reference Predicate	Similarities / Differences
	The Alma Hybrid ProScan 1570nm fractional applicator, with wavelength of 1570 nm, is indicated for: Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue The Alma Hybrid ProScan CO2 &1570nm fractional applicator, with wavelengths of 10600 nm & 1570nm is indicated for laser skin resurfacing (ablation and/or vaporization) of soft tissue.	including aphthous ulcers; • Incision of infection when used with antibiotic therapy; • Frenectomy (frenum release); • Excision and ablation of benign and malignant lesions; • Homeostasis; • Operculectomy; • Crown lengthening; • Removal of soft tissue, cysts and tumors; • Oral cavity tumors and hemangiomas; • Abscesses; • Extraction site hemostasis; • Salivary gland pathologies;	including aphthous ulcers; • Incision of infection when used with antibiotic therapy; • Frenectomy (frenum release); • Excision and ablation of benign and malignant lesions; • Homeostasis; • Operculectomy; • Crown lengthening; • Removal of soft tissue, cysts and tumors; • Oral cavity tumors and hemangiomas; • Abscesses; • Extraction site hemostasis; • Salivary gland pathologies;

Page 43

Parameter	Subject Device	Primary Predicate	Reference Predicate	Similarities / Differences
		• Pre-prosthetic gum preparation; • Leukoplakia; • Partial glossectomy; • Periodontal gum resection. Genitourinary Incision/excision and vaporization and of soft tissue in genitourinary procedures. Applications include: • Benign and malignant lesions of external genitalia; • Condyloma; • Phimosis • Erythroplasia	• Pre-prosthetic gum preparation; • Leukoplakia; • Partial glossectomy; • Periodontal gum resection. Genitourinary Incision/excision and vaporization and of soft tissue in genitourinary procedures. Applications include: • Benign and malignant lesions of external genitalia; • Condyloma; • Phimosis • Erythroplasia

VI. Summary of technological characteristics of the device compared to the predicates [21 CFR 807.92(a)(6)]

The technical characteristics for the Alma Hybrid Laser System are substantially equivalent to the K203441 and K103501 devices.

Page 44

VII. Performance Testing [21 CFR 807.92(b)(1)]- Performed under K230441

• IEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements for safety
• IEC 60601-1-2 Medical Electrical Equipment 1-2 General Requirements for basic safety and essential performance – Electromagnetic Compatibility
• IEC 60601-2-22 Medical Electrical Equipment-Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
• IEC 60825-1 Safety of laser products-Part 1: Equipment Classification, requirements and user's guide
• ISO 10993-1 Biological evaluation of medical devices -- Part 1
• ISO 17665-1 Sterilization of health care products – moist heat
• IEC 62304 Medical Device Software
• ISO 14971 Risk Analysis

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VIII. Clinical Data [21 CFR 807.92(b) (2)]

Based on the similarities in the safety and effectiveness profiles of the subject and the predicate, no human clinical studies were deemed needed to support this submission.

IX. Conclusions Safety and Effectiveness SE [21 CFR 807.92(b) (3)]

The Alma Hybrid Laser System is as safe and effective as the predicate devices. The proposed Alma Hybrid Laser System has the same intended use and indications as the predicate with proposed expanded indications, similar technological characteristics, and the same principles of operation as its predicate devices. Thus, the Alma Hybrid Laser System is substantially equivalent to its predicate.

Summary of Supporting Data:

A risk assessment and supporting documentation demonstrate that the change does not affect the safety and effectiveness of the device. No new testing is required beyond what was included in the previously cleared submission.

Conclusion:

The modified device, incorporating the new indication for use, remains substantially equivalent to the previously cleared version under Original 510(k) K230441

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.