The UltraPulse system (UltraPulse DUO models, members of the modified Lumenis Family of UltraPulse SurgiTouch CO2 Surgical Lasers) is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology (including laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery.

The UltraPulse system (UltraPulse DUO models, members of the modified Lumenis Family of UltraPulse SurgiTouch CO2 Surgical Lasers) is indicated for use in the performance of specific surgical applications in aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (including laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery 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) for treatment of:
· Wrinkles, rhytids, and furrows (including fine lines and texture irregularities).
-Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of:
Keratoses, including actinic and sebortheic keratosis, sebortheic wart and verruca sebortheica.
· Vermillionectomy 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 granuloma pyogenicum/granuloma telangiectaticum)
Tattoos
· Telangiectasia
· Removal of small skin tumors, including periungual (Koenen) and subungual fibromas
· Superficial pigmented lesions
Adenosebaceous 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
· Tricoepitheliomas
Xanthelasma palpebrarum
Syringoma
-Laser ablation, vaporization and/or excision for complete and partial nail matrixectomy. Vaporization or coagulation of:
· Benign and malignant vascular/avascular skin lesions
· Moh's Surgery
· Lipectomy
Verrucae and seborrhoecae vulgares, including paronychial, periungal, 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 vulgares/plantar (warts), including paronychial, periungal and subungual warts
Porokeratoma ablation
· Ingrown nail treatment
· Neuromas/fibromas, including Morton's neuroma
Debridement of ulcers
Other soft tissue lesions
-Laser ablation, vaporization, and/or excision for complete and partial matrixectomy

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

· Choanal atresia
· Leukoplakia, including oral, larynx, uvula, palatal, and 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, 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 structures and tissue
· Zenker's Diverticulum/pharyngoesophageal diverticulum (endoscopic laser-assisted esophagodiverticulostomy (ELAED))
· Stenosis, including subglottic stenosis
· Tonsillectomy (including tonsillar cryptolysis and neoplasma) and tonsil ablation/tonsillotomy
· Pulmonary bronchial and tracheal lesion removal
· Benign and malignant nodules, tumors and fibromas (larynx, 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 of oral, subfacial and neck tissues
Rhinophyma
Verrucae vulgares (warts)
Gingivoplasty/gingivectomy

Gynecology (GYN)
-Laser incision, excision, ablation and/or vaporization of soft tissue in gynecology for the treatment of:
· Conization of the cervix, including cervical intraepithelial neoplasia (CIN), and vulvar and vaginal intraepithelial neoplasia (VIN, VAIN)
· Condyloma acuminata, including cervical, genital, vulvar, perineal, and Bowen's disease (Erythrolasia of Queyrat) and Bowenoid papulosa (BP) lesions

· Leukoplakia (vulvar dystrophies)
· Incision and drainage (I&D) of Bartholin's and nubuthian 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 gynecological laparoscopy, for the treatment of:
· Endometrial lesions, including ablation of endometriosis
Excision/lysis 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 of soft tissue in neurosurgery for the treatment of:

Cranial

Posterior fossa tumors
· Peripheral neurectomy
· Benign and malignant tumors and cysts, for example, gliomas, meningiomas (including basal tumors), acoustic neuromas, lipomas, and large tumors
Arteriovenous malformation
· Pituitary gland tumors (transphenoidal approach)

Spinal cord

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

Orthopedic
-Incision/excision and vaporization of soft tissue in orthopedic surgery, including the following applications:

Arthroscopy
· Menisectomy
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 and Thoracic Surgery
-Incision, excision and vaporization 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 and Oral Surgery
-Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include:

· Gingivectomy/removal of hyperplasias
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
· Preprosthetic gum preparation
Leukoplakia
· Partial glossectomy
Periodontal gum resection

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

Benign and malignant lesions of external genitalia
Condyloma
Phimosis
· Erythroplasia

Device Description

The modified UltraPulse System, member of the UltraPulse SurgiTouch Family of CO2 Surgical and Aesthetic Laser Systems, Delivery Devices and Accessories (K951812 K912029, K96339 K030147 and K151331), is a carbon dioxide laser system based on a Radio Frequency (RF) modulated CO2 laser tube.

The modified UltraPulse is based on the following hardware components in the Lumenis Family of UltraPulse CO2 Laser System, Delivery Devices and Accessories:

. A Laser Console with a Free Beam Port to which an articulated arm is attached
A footswitch to activate the laser treatment beam and allow the selected laser energy to be transmitted via the delivery device to the target location.
A variety of Free Beam Delivery Device and accessories

The modified UltraPulse, similarly to the recent members of the cleared Lumenis Family of UltraPulse CO2 Surgical and Aesthetic Laser Systems. Delivery Devices and Accessories (UltraPulse and UltraPulse DUO models) has a similar proprietary software, which is embedded in the Main Controller, Peripheral Controller units and PC.

The modified UltraPulse CO2 Laser System, is a version of the cleared Lumenis Family of UltraPulse CO2 Laser System, Devices and Accessories (see K030147 and K151331 for the latest clearances) with modifications to meet the marketing requirements for a new system with a subset of the supported aesthetic and surgical scanners and accessories. The modified UltraPulse System now supports the Aesthetic Scanners, UltraScan CPG and DeepFX Microscanner used with the cleared UltraPulse SurgiTouch/Encore Systems but with a modern GUI, PC and Operating System. In addition, other hardware, electronic and Software changes were introduced to replace obsolete components. The proposed system relies on the same fundamental underlying technology of the cleared systems with some modifications as compared to the cleared family members.

In addition, this submission describes several minor post-clearance modifications to the cleared Lumenis Family of Surgical and Aesthetic Laser Systems, Delivery Devices and Accessories that were the subject of contemporary regulatory analyses that determined that changes could not significantly affect safety or effectiveness. Accordingly, these post-clearance modifications were implemented via internal documentation and no pre-marketing submission was filed. The postclearance modifications, include addition of the modified SurgiTouch Scanner (cleared under K951812 and K022060), called the DeepFX Microscanner to the UltraPulse SurgiTouch/Encore system, almost identical to the AcuScan120 Microscanner cleared with the Lumenis AcuPulse CO2 Laser system (K100415). Modernization of electronics and hardware of all systems to replace outdated parts and to meet new contemporary standards (e.g., IEC 60601-1-2 Ed.4, IEC 60601-1 Ed 3.1), improvements in laser calibration and stability and finally minor software modifications to enhance the user workflow and accessories supported (e.g., addition of treatment Preference and Utilities Screens and Training Videos).

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, the UltraPulse Surgical and Aesthetic CO2 Laser System. It is focused on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving a new medical claim or showing improved clinical effectiveness. Therefore, the typical elements of an AI/ML device study (like sample size for test/training, expert adjudication, MRMC studies, or specific performance metrics like sensitivity/specificity for a diagnostic algorithm) are not applicable here.

This submission is for a physical laser system (hardware and software that controls it), not for an AI/ML diagnostic or prognostic algorithm. The acceptance criteria and supporting studies are centered on compliance with safety standards and functional equivalence to its predicate, rather than clinical performance metrics.

Here's an analysis based on the provided document:

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

Since this is a submission for a physical laser device and not a diagnostic AI/ML algorithm, the acceptance criteria are not typically presented in terms of clinical performance metrics like sensitivity, specificity, or AUC, as would be common for AI/ML. Instead, they are related to safety, functionality, and equivalence to the predicate device. The document describes the studies performed to verify these, rather than providing a quantitative table of achieved "performance" against acceptance criteria for a new clinical claim.

The document implicitly states that the "acceptance criteria" were met by showing that the modified device:

Conformed to relevant electrical, laser, and electromagnetic compatibility safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1).
Underwent software verification and validation according to IEC 62304 and FDA guidance.
Passed system testing for basic functionalities (energy measurements, safety controls, emission indicator, scanners, aiming beam).
Underwent usability assessment per FDA guidance and IEC standards.
Evaluated changes to accessories, reprocessing, and biocompatibility.

The "reported device performance" is summarized as: "Test results indicated that the modified UltraPulse performs in accordance with its requirements and specifications similarly to its predicate UltraPulse System member of the Lumenis Family of UltraPulse SurgiTouch CO2 Surgical and Aesthetic Laser Systems."

2. Sample size used for the test set and the data provenance:

Not applicable in the context of AI/ML diagnostic/prognostic models. For a physical device verification, "sample size" doesn't refer to a dataset of patient images/samples. Instead, it refers to the number of units tested, or the scope of testing performed according to engineering and quality assurance protocols. The document does not specify a numerical count of devices or components tested, but implies comprehensive testing of the modified system.
Data Provenance: The data would be internally generated from engineering and quality assurance testing in Israel (Lumenis Ltd. is based in Yokneam, Israel) during the device development and verification process. It is neither retrospective nor prospective in the common sense of clinical studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This submission is for a physical laser device, not an AI/ML system requiring expert-annotated ground truth for clinical decision support. The "ground truth" for this device's performance would be established by objective measurements and adherence to engineering specifications and safety standards, not by human expert consensus on clinical data.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies to establish a consensus (ground truth) among multiple human readers for diagnostic tasks. This is irrelevant for a hardware/software system verification for substantial equivalence.

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:

No. This is a hardware/software laser system, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance was not conducted and is not relevant for this 510(k) submission.

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

Not applicable. This is a device that performs a physical action (laser ablation/vaporization). Its "performance" is inherent to its functional specifications and safety, not a standalone diagnostic algorithm.

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

For physical device verification and validation, "ground truth" is established by:
- Engineering specifications and design requirements: The device must perform as designed.
- International standards: Adherence to electrical safety (e.g., IEC 60601-1), laser safety (e.g., IEC 60825-1), EMC (e.g., IEC 60601-1-2), and software development standards (e.g., IEC 62304).
- Risk analysis (ISO 14971): Ensuring identified risks are mitigated.
- Predicate device's established performance: The modified device must perform "similarly" to the cleared predicate.

8. The sample size for the training set:

Not applicable. This is not an AI/ML algorithm that requires a training set. The software for this device is likely developed using traditional software engineering paradigms, validated through testing, not "trained" on data.

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

Not applicable. As above, no training set for an AI/ML model.

In summary, this 510(k) is about demonstrating the safety and effectiveness of a modified CO2 laser system through adherence to engineering standards, risk analysis, and substantial equivalence to a predicate device. It is not an AI/ML product seeking clearance based on diagnostic performance metrics.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 24, 2020

Lumenis Ltd. Shlomit Segman RA Director 6 Hakidma Street PO Box 240 Yokneam. Yokneam 2069204 Israel

Re: K203544

Trade/Device Name: UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories 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 Dated: November 25, 2020 Received: December 4, 2020

Dear Shlomit Segman:

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 (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 located 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-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/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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-device-advice-comprehensive-regulatoryassistance/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.

Purva Pandya 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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Device Name

UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices, and Accessories

Indications for Use (Describe)

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) for treatment of:

· Wrinkles, rhytids, and furrows (including fine lines and texture irregularities).
-Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of:
Keratoses, including actinic and sebortheic keratosis, sebortheic wart and verruca sebortheica.
· Vermillionectomy 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 granuloma pyogenicum/granuloma telangiectaticum)

Tattoos
· Telangiectasia
· Removal of small skin tumors, including periungual (Koenen) and subungual fibromas
· Superficial pigmented lesions
Adenosebaceous hypertrophy or sebaceous hyperplasia

• Rhinophyma reduction

FORM FDA 3881 (1/14)

{3}------------------------------------------------

· 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
· Tricoepitheliomas
Xanthelasma palpebrarum
Syringoma

-Laser ablation, vaporization and/or excision for complete and partial nail matrixectomy. Vaporization or coagulation of:

· Benign and malignant vascular/avascular skin lesions
· Moh's Surgery
· Lipectomy
Verrucae and seborrhoecae vulgares, including paronychial, periungal, 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 vulgares/plantar (warts), including paronychial, periungal and subungual warts
Porokeratoma ablation
· Ingrown nail treatment
· Neuromas/fibromas, including Morton's neuroma
Debridement of ulcers
Other soft tissue lesions

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

Otolaryngology (ENT)

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

· Choanal atresia
· Leukoplakia, including oral, larynx, uvula, palatal, and 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, 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 structures and tissue
· Zenker's Diverticulum/pharyngoesophageal diverticulum (endoscopic laser-assisted esophagodiverticulostomy (ELAED))
· Stenosis, including subglottic stenosis
· Tonsillectomy (including tonsillar cryptolysis and neoplasma) and tonsil ablation/tonsillotomy
· Pulmonary bronchial and tracheal lesion removal

{4}------------------------------------------------

· Benign and malignant nodules, tumors and fibromas (larynx, 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 of oral, subfacial and neck tissues
Rhinophyma
Verrucae vulgares (warts)
Gingivoplasty/gingivectomy

Gynecology (GYN)

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

· Conization of the cervix, including cervical intraepithelial neoplasia (CIN), and vulvar and vaginal intraepithelial neoplasia (VIN, VAIN)

· Condyloma acuminata, including cervical, genital, vulvar, perineal, and Bowen's disease (Erythrolasia of Queyrat) and Bowenoid papulosa (BP) lesions

· Leukoplakia (vulvar dystrophies)
· Incision and drainage (I&D) of Bartholin's and nubuthian 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 gynecological laparoscopy, for the treatment of:
· Endometrial lesions, including ablation of endometriosis
Excision/lysis adhesions
· Salpingostomy
Oophorectomy/ovariectomy
· Fimbrioplasty
Metroplasty
· Microsurgery (tubal)
· Uterine myomas and fibroids
· Ovarian fibromas and follicle cysts
· Uterosacral ligament ablation
· Hysterectomy

Neurosurgery

{5}------------------------------------------------

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

Cranial

Posterior fossa tumors
· Peripheral neurectomy

· Benign and malignant tumors and cysts, for example, gliomas, meningiomas (including basal tumors), acoustic neuromas, lipomas, and large tumors

Arteriovenous malformation
· Pituitary gland tumors (transphenoidal approach)

Spinal cord

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

Orthopedic

-Incision/excision and vaporization of soft tissue in orthopedic surgery, including the following applications:

Arthroscopy
· Menisectomy
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 and Thoracic Surgery

-Incision, excision and vaporization 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

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· Cysts, including sebaceous cysts, pilar cysts, and mucous cysts of the lips

· Pilonidal cyst removal and repair
Abscesses
· Other soft tissue applications

Dental and Oral Surgery

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

· Gingivectomy/removal of hyperplasias
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
· Preprosthetic gum preparation
Leukoplakia
· Partial glossectomy
Periodontal gum resection

Genitourinary

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

Benign and malignant lesions of external genitalia
Condyloma
Phimosis
· Erythroplasia

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

0ver-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/8/Picture/0 description: The image shows the text 'K203544' in a bold, sans-serif font. The text is black and appears to be on a white background. The letters and numbers are evenly spaced and clearly legible.

Image /page/8/Picture/1 description: The image shows the logo for Lumenis. The logo consists of a dark blue circle with a white "L" inside of it. To the right of the circle is the word "Lumenis" in a sans-serif font, also in dark blue.

510(K) SUMMARY

The Modified UltraPulse System (member of the Lumenis Family of UltraPulse SurgiTouch CO₂ Surgical and Aesthetic Lasers, Delivery Devices and Accessories)

Applicant Name:	Lumenis Ltd.6 Hakidma Street PO Box 240Yokneam Industrial Park,Yokneam 2069204, IsraelTel: +972-4-9599000Fax: +972-4-9599046
Contact Person:	Shlomit Segman Lumenis Ltd.6 Hakidma Street PO Box 240,Yokneam Industrial Park,Yokneam 2069204, IsraelTel: +972-4-9599230Fax: +972-4-9599198Email:Shlomit.Segman@lumenis.com
Date Prepared:	25 November 2020
Trade Name:	The modified UltraPulse System (member of the Lumenis Family ofUltraPulse SurgiTouch CO2 Surgical and Aesthetic Lasers, DeliveryDevices and Accessories)
Classification	Powered laser surgical instrument
Name: Product	GEX
Code: Device Class:	Class II
Regulation Number:	21 CFR 878.4810
Panel:	General & Plastic Surgery
Predicate Devices:	Lumenis Family of UltraPulse SurgiTouch CO2 Lasers, DeliveryDevices and Accessories, recently cleared under K151331.
Reference Devices:	Previous Versions of Subject: K051812 K012029 K063339 K030147

Intended Use/ Indications for Use:

The modified UltraPulse CO2 Laser System, Delivery Devices and Accessories shares with its predicate exactly the same intended use. Accordingly, the Indications for Use statement of the modified subject system, as presented below, is identical to the statement cleared under K151331.

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Image /page/9/Picture/0 description: The image shows the logo for Lumenis. The logo consists of a stylized "L" inside a dark blue circle on the left, followed by the word "Lumenis" in a simple, sans-serif font. A small registered trademark symbol appears to the upper right of the word "Lumenis".

The modified UltraPulse System, subject of this submission as well as its cleared UltraPulse SurgiTouch Family of CO2 Aesthetic and Surgical Laser systems (UltraPulse SurgiTouch, UltraPulse Encore, UltraPulse and UltraPulse DUO members), Delivery Devices and Accessories are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology (including laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery.

The modified UltraPulse model, subject of this submission as well as its cleared UltraPulse SurgiTouch Family of Surgical and Aesthetic CO2 Laser systems (UltraPulse SurgiTouch, UltraPulse Encore, and UltraPulse DUO members), Delivery Devices and Accessories are indicated for use in the performance of specific surgical applications in aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology (including laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery 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) for treatment of:

. Wrinkles, rhytids, and furrows (including fine lines and texture irregularities).
Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of:
Keratoses, including actinic and seborrheic keratosis, seborrhoecae vulgares, seborrheic wart and verruca seborrheica.
Vermillionectomy 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 telangiectaticum)
Tattoos
Telangiectasia

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Removal of small skin tumors, including periunqual (Koenen) and subungual fibromas ●
Superficial pigmented lesions
Adenosebaceous 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
Tricoepitheliomas ●
. Xanthelasma palpebrarum
. Syringoma

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

Vaporization or coagulation of:

. Benign and malignant vascular/avascular skin lesions
Moh's Surgery
Lipectomy
Verrucae and seborrhoecae vulgares, including paronychial, periungal, 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

Podiatrv

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

Verrucae vulgares/plantar (warts), including paronychial, periungal and subungual warts ●
Porokeratoma ablation ●
Ingrown nail treatment ●
. Neuromas/fibromas, including Morton's neuroma
Debridement of ulcers
Other soft tissue lesions

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

Otolaryngology (ENT)

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

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Image /page/11/Picture/0 description: The image shows the logo for Lumenis. The logo consists of a stylized letter "L" inside a dark blue circle, followed by the word "Lumenis" in a simple, sans-serif font. A registered trademark symbol is located to the right of the word.

Choanal atresia
Leukoplakia, including oral, larynx, uvula, palatal, and 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 structures and tissue .
Zenker's Diverticulum/pharyngoesophageal diverticulum (endoscopic laser-assisted esophagodiverticulostomy (ELAED))
. Stenosis, including subglottic stenosis
. Tonsillectomy (including tonsillar cryptolysis and 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)
. Cordectorny, 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 of oral, subfacial and neck tissues
Rhinophyma
Verrucae vulgares (warts) ●
Gingivoplasty/gingivectomy ●

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Image /page/12/Picture/0 description: The image shows the logo for Lumenis. The logo consists of a stylized letter "U" inside of a circle on the left, followed by the word "Lumenis" in a sans-serif font. A registered trademark symbol is located to the upper right of the word "Lumenis".

Gynecology (GYN)

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

. Conization of the cervix, including cervical intraepithelial neoplasia (CIN), and vulvar and vaginal intraepithelial neoplasia (VIN, VAIN)
Condyloma acuminata, including cervical, genital, vulvar, perineal, and Bowen's disease ● (Erythrolasia of Queyrat) and Bowenoid papulosa (BP) lesions
Leukoplakia (vulvar dystrophies)
Incision and drainage (I&D) of Bartholin's and nubuthian 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 gynecological laparoscopy, for the treatment of:

Endometrial lesions, including ablation of endometriosis ●
Excision/lysis 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 of soft tissue in neurosurgery for the treatment of:

Cranial

Posterior fossa tumors ●
Peripheral neurectomy ●
. Benign and malignant tumors and cysts, for example, gliomas, meningiomas (including basal tumors), acoustic neuromas, lipomas, and large tumors
. Arteriovenous malformation
. Pituitary gland tumors (transphenoidal approach)

The modified UltraPulse System 510K Summary 510(k) Summarv Page 5 of 9

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Image /page/13/Picture/0 description: The image shows the logo for Lumenis. The logo consists of a stylized letter "L" inside a circle on the left, followed by the word "Lumenis" in a sans-serif font. There is a small dot above the "i" in "Lumenis", and a registered trademark symbol to the right of the word.

Spinal cord

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

Orthopedic

Incision/excision and vaporization of soft tissue in orthopedic surgery, including the following applications:

. Arthroscopy
Menisectomy ●
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 and Thoracic Surgery

Incision, excision and vaporization 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 ●

The modified UltraPulse System 510K Summary 510(k) Summarv Page 6 of 9

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Image /page/14/Picture/0 description: The image shows the logo for Lumenis. The logo consists of a stylized letter "L" inside of a circle, followed by the word "Lumenis" in a sans-serif font. A registration mark is present to the right of the word "Lumenis".

Dental and Oral Surgery

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

Gingivectomy/removal of hyperplasias .
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
Preprosthetic gum preparation ●
Leukoplakia
Partial glossectomy
Periodontal gum resection ●

Genitourinary

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

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

Device Description:

The modified UltraPulse is based on the following hardware components in the Lumenis Family of UltraPulse CO2 Laser System, Delivery Devices and Accessories:

. A Laser Console with a Free Beam Port to which an articulated arm is attached
A footswitch to activate the laser treatment beam and allow the selected laser energy to be transmitted via the delivery device to the target location.
A variety of Free Beam Delivery Device and accessories ●

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Image /page/15/Picture/0 description: The image shows the logo for Lumenis. The logo consists of a stylized letter "U" in dark blue, followed by the word "Lumenis" in a lighter shade of blue. A registered trademark symbol is located to the upper right of the word "Lumenis".

Substantial Equivalence

The modified UltraPulse System, subject of this submission, is a modification of the Lumenis UltraPulse System (member of the UltraPulse SurgiTouch Family CO2 Lasers Systems, Delivery Devices and Accessories) cleared under K151331. It is regarded as a modified member to the UltraPulse SurgiTouch CO2 Laser family, Delivery Devices and Accessories. As such it shares with the cleared family members, the same intended use and underlying technology. The modifications introduced to the subject UltraPulse System as compared to its cleared family are designed and intended mainly for system modernization and increased user convenience in accordance with market/design inputs.

Design verification and validation processes were performed as a result of this risk analysis assessment to verify that no different questions of safety and effectiveness have been raised due to the modifications to this system. The test methods are essentially the same as those used to support to the clearance of the Family of UltraPulse SurgiTouch CO2 Lasers and other Lumenis CO2 laser systems (see K030147 and K151331 for the latest clearances).

The modified UltraPulse System 510K Summary 510(k) Summary Page 8 of 9

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The following activities were performed:

Risk analysis per ISO 14971
. Electrical, laser and electromagnetic compatibility safety testing according to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22 and IEC 60825-1
. Software verification and validation according to IEC 62304 and FDA Guidance "Principles of Software Validation Guidance for Industry and FDA Staff, January 2002".
. System testing (e.q., energy measurements, safety controls, emission indicator, scanners, aiming beam).
. Usability assessment to ensure that the usability of the modified system was not affected according to FDA Guidance Applying Human Factors and Usability Engineering to Medical Devices, February 2016", IEC 62366-1 and IEC 60601-1-6.
As part of the Design Controls, the changes performed to the accessories since their clearance were evaluated. Reprocessing evaluation according to ISO 17665-1 and FDA's guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling FDA Guidance (2015, Updated June 9, 2017)". Biocompatibility evaluation according to ISO 10993-1 and FDA Guidance "Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing with a Risk Management Process, September 2020". To date, no significant change in contact materials and processes of the Delivery Devices and accessories were performed since their clearance and/or release. Also no changes were performed in the contact parts and processes in order to work with the modified UltraPulse System, therefore it was concluded that no biocompatibility issues are raised and the biocompatibility data submitted in the previous 510(k) notices remains applicable to the modified device described in this submission.

Test results indicated that the modified UltraPulse performs in accordance with its requirements and specifications similarly to its predicate UltraPulse System member of the Lumenis Family of UltraPulse SurgiTouch CO2 Surgical and Aesthetic Laser Systems. Consequently, Lumenis Ltd. believes that the modified UltraPulse CO2 Laser System, Delivery Devices and Accessories is substantially equivalent to the cleared predicate and it does not raise any different questions of safety and/or effectiveness.

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.