(30 days)
No.
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description details hardware components without mentioning AI capabilities.
Yes.
The device is intended for use in "surgical applications," "treatment of wrinkles," "acne scars," "removal of small skin tumors," "fungal nail treatment," etc., which are therapeutic purposes. It is also explicitly stated in the Performance Testing section, "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".
No
Explanation: The device description and intended use clearly state that the Alma Hybrid Laser System is used for surgical applications involving ablation, vaporization, excision, incision, and coagulation of soft tissue. These are therapeutic and operative actions, not diagnostic ones. Performance studies mentioned are for safety and effectiveness, not diagnostic accuracy.
No
The device is a laser system with physical components (console, articulated arm, footswitch, applicators) designed for surgical applications, not a software-only medical device. While it contains "system software," this software controls hardware and is not the primary regulated component.
No
The device is a surgical laser system used for ablating, vaporizing, excising, incising, and coagulating soft tissue, which are direct medical interventions on the body, not analyses of in-vitro samples.
N/A
Intended Use / 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
- 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 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
- 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.
Product codes (comma separated list FDA assigned to the subject device)
GEX, ONG
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)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue in various medical specialties including:
- Dermatology and plastic surgery (e.g., skin, lip, nails, eyelids)
- Podiatry (e.g., foot, nails)
- Otolaryngology (ENT) (e.g., ear, nose, larynx, pharynx, trachea, oral cavity, uvula, palatal, upper lateral pharyngeal tissue, tonsils, bronchial)
- Gynecology (GYN) (e.g., cervix, vulvar, vaginal, perineal, Bartholin's and Nabothian cysts, urethra, endometrium, adhesions, fallopian tubes, ovaries, uterus, uterosacral ligament)
- Neurosurgery (e.g., posterior fossa, peripheral nerves, pituitary gland, spinal cord, intra- and extradural lesions)
- Orthopedics (e.g., joints, traumatic wounds, decubitus and diabetic ulcers)
- General/Thoracic Surgery (e.g., decubitus ulcers, stasis ulcers, diabetic ulcers, burns, rectum, anus, breast, mediastinum, thoracic region, skin, cysts)
- Dental/Oral Surgery (e.g., gingiva, oral cavity, salivary glands)
- Genitourinary (e.g., external genitalia)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted under K230441 by meeting the standards of:
- 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
No human clinical studies were deemed needed to support this submission. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
Page 7
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 Street |
| NORTH INDUSTRIAL PARK | |
| CAESAREA , IL 3079895 | |
| Contact Person | Jessica Rivera-Montejo Assoc. Director of Regulatory |
| Email: regulatory@almalasers.com | |
| Phone: 224-377-2019 | |
| 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, |