The LightSheer pulsed diode array laser systems are indicated for use in surgical, aesthetic, and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology. The LightSheer pulsed diode array laser systems are intended for use on all skin types (Fitzpatrick skin types I – VI), including tanned skin.

The LightSheer Desire Light Laser System with LightSheer ET/XC Laser Handpiece is indicated for the treatment of vascular lesions, including angiomas, telangiectasia and other benign vascular lesions, the treatment of Pseudofolliculitis Barbae (PFB). The LightSheer Desire Light Laser System with LightSheer ET/XC Laser Handpiece is also indicated for hair removal, permanent hair reduction* and the treatment of benign pigmented lesions and leg veins.

Note: Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

Device Description

The modified LightSheer Desire Light Laser System is a non-invasive aesthetic laser system that delivers pulsed infrared laser light with a wavelength ranging from 790-830 nm (805 nm nominal). The system consists of a laser console and two optional handpieces, ET or XC, which can be connected to the console, one at a time, via a universal plug-in connector and an umbilical cable.

The ET handpiece; delivers laser energy through a 9mm tip up to 81 J maximum. The settings for this handpiece are selectable pulse duration from 5-400 ms, selectable fluency from 10-100 J/cm² and a pulse repetition rate up to 3 Hz maximum. The XC handpiece; delivers laser energy through a 12mm x 12mm tip up to 58 J maximum. The settings for this handpiece are selectable pulse duration from 5-400 ms, selectable fluency from 10-40 J/cm² and a pulse repetition rate up to 3 Hz maximum

The laser system delivers pulsed infrared laser light from the diode array in the ET or XC handpiece to the treatment area. In standard use, the handpiece is pressed against the patient's skin and a pulse of light is delivered. To initiate energy output, the system requires redundant activation of the handpiece enable button and the handpiece trigger button while the system is in the Ready mode.

The ET and XC handpieces include a chilled sapphire tip that is water-cooled to provide active skin cooling. The physician is able to control the settings of laser energy from the LCD display on the main console.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the "LightSheer Desire Light Laser System." This document establishes substantial equivalence to a predicate device rather than focusing on specific performance metrics against pre-defined acceptance criteria for a new device. Therefore, it does not contain the detailed information necessary to fully answer all aspects of your request as it pertains to acceptance criteria and a study proving those criteria.

However, based on the information provided, here's what can be extracted and inferred:

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

The document does not present specific quantitative acceptance criteria or a table of performance metrics in the way one might expect for a study proving device performance against such criteria. Instead, it states that "Test results indicated that the subject LightSheer Desire Light Laser System performs in accordance with its requirements and specifications, in similarity to its predicate device."

The "performance" in this context refers to demonstrating that the modified device functions comparably to its predicate and meets safety standards. The categories of testing performed are:

Acceptance Criteria Category (Inferred from testing performed)	Reported Device Performance (General Statement)
Risk analysis (ISO 14971 compliance)	Performed; device adheres to safety standards.
Electrical and laser safety (EN 60601-1-2, EN 60601-1, EN 60601-2-22, EN 60825-1 compliance)	Performed; device conforms to these performance standards.
Electromagnetic compatibility (EMC)	Performed; device conforms to standards.
Software verification and validation	Performed; software functions as intended.
Environmental testing (operation, storage, transportation)	Performed; device withstands variant conditions.
System testing (handpiece use, authorization, treatment parameters, energy measurements, handpiece replacement, handpiece cooling, safety controls)	Performed; device performs in accordance with requirements and specifications.

The ultimate "acceptance criterion" for this 510(k) submission is that the device is "substantially equivalent" to the predicate device in terms of safety and effectiveness, and the document concludes that it meets this.

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

The document does not specify a "test set" in the context of clinical data for performance evaluation. The testing described (electrical, software, environmental, system) suggests a regulatory/engineering testing approach rather than a clinical study with a patient sample size. There is no mention of country of origin of data or whether it was retrospective or prospective, as no clinical data set is referenced.

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

Not applicable. This type of information is generally relevant for clinical studies involving expert interpretation of medical images or outcomes, which is not the primary focus of the performance testing described here. The "ground truth" for electrical safety, software function, etc., is based on engineering specifications and regulatory standards.

4. Adjudication method for the test set

Not applicable, as no human-reviewed data sets or adjudications are mentioned.

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

Not applicable. This device is a laser system, not an AI-powered diagnostic or assistive tool for human readers.

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

This refers to the performance of the device itself as a physical system, rather than an algorithm. The "System testing" mentioned (e.g., energy measurements, handpiece cooling, safety controls) represents the standalone performance evaluation of the device's functional aspects. The document implies these tests were performed to ensure the device operates according to its specifications.

7. The type of ground truth used

The "ground truth" for the tests performed are primarily the engineering specifications, design requirements, and international safety standards (e.g., EN 60601-1, EN 60825-1, ISO 14971) against which the device's electrical, laser, mechanical, and software functionality were evaluated. For example, for "energy measurements," the ground truth would be the expected energy output within a specific tolerance, as defined by the device's design specifications.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this device is not an AI/machine learning system that requires training data.

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

Not applicable for the same reason as #8.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 12, 2015

Lumenis Ltd. Ms. Elissa Burg Director of Regulatory Affairs & Quality Systems Yokneam Industrial Park Yokneam 2069204, Israel

Re: K151947

Trade/Device Name: LightSheer Desire Light 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 Dated: July 12, 2015 Received: July 15, 2015

Dear Ms. Burg:

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. 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.

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

{1}------------------------------------------------

CFR Part 807); labeling (21 CFR [SELECT ONE: Part 801 [or, for IVDs only] Parts 801 and 809]); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

{2}------------------------------------------------

Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.

510(k) Number ( if known )	K151947
Device Name	LightSheer Desire Light Laser System

Indications for Use (Describe)
The LightSheer pulsed diode array laser systems are indicated for use in surgical, aesthetic, and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology. The LightSheer pulsed diode array laser systems are intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.

The LightSheer Desire Light Laser System with LightSheer ET/XC Laser Handpiece is indicated for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia and other benign vascular lesions, the treatment of Pseudofolliculitis Barbae (PFB). The LightSheer Desire Light Laser System with LightSheer ET/XC Laser Handpiece is also indicated for hair removal, permanent hair reduction* and the treatment of benign pigmented lesions and leg veins.

Note: Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)	Page 1 of 1
----------------------	-------------

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

510(K) SUMMARY

Image /page/3/Picture/1 description: The image shows the Lumenis logo. The logo consists of a blue letter "L" inside of a blue circle on the left, followed by the word "Lumenis" in blue. Below the word "Lumenis" is the phrase "Energy to Healthcare" in a smaller blue font.

LightSheer Desire Light Laser System

Applicant Name:	Lumenis Ltd.6 Hakidma Street PO Box 240Yokneam Industrial Park,Yokneam 2069204, IsraelTel: +972-4-9599000Fax: +972-4-9599046
Contact Person:	Elissa Burg - Director of Regulatory Affairs & Quality SystemsLumenis Ltd.
	6 Hakidma Street PO Box 240Yokneam Industrial Park,Yokneam 2069204, IsraelTel: +972-4-9599168Fax: +972-4-9599198Mail: Elissa.Burg@lumenis.com
Date Prepared:	August 09, 2015
Trade Name:	LightSheer Desire Light Laser System
Common Name:	Pulsed Diode Array Laser
Classification Name:	Powered laser surgical instrument
Product Code:	GEX
Device Class:	Class II
Regulation Number:	21 CFR 878.4810
Panel:	General & Plastic Surgery
Predicate Device:	LightSheer Duet Laser System, cleared under K053628.

Special 510(k) LightSheer Desire Light Laser System

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

Intended Use/ Indications for Use:

Note: Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

Modified Device Description:

Special 510(k) LightSheer Desire Light Laser System

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

Substantial Equivalence

The intended use and indications for use of the LightSheer Desire Light Laser System are identical to the intended use and indications for use of its predicate device. In addition, the same technological characteristics and principles of operation apply for both systems. The modifications introduced to the subject LightSheer Desire Light Laser System as compared to the predicate system are designed and intended mainly for updating the system industrial design to form a table top console and increased user convenience.

Performance testing was conducted in order to demonstrate the performance of the LightSheer Desire Light Laser System and its substantial equivalence, with respect to the safety and effectiveness, to the cleared predicate system. The following activities were performed:

Risk analysis activities in compliance with the requirements of ISO 14971.
. Electrical and laser safety and electromagnetic compatibility testing as required to conform to with the following performance standards:
- । EN 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- requirements and tests.
- EN 60601-1: Medical electrical equipment Part 1: General requirements for । basic safety and essential performance.
- EN 60601-2-22: Medical electrical equipment- part 2: particular requirements for । the safety of diagnostic and therapeutic laser equipment.
- । EN 60825-1: Safety of laser products-Part 1: Equipment classification and requirements.
Software verification and validation testing.
. Environmental testing demonstrating the ability of the subject system to withstand variant operation, storage and transportation conditions.
. System testing (e.g. handpieces use and authorization, treatment parameters, energy measurements, handpiece replacement, handpiece cooling, safety controls).

Test results indicated that the subject LightSheer Desire Light Laser System performs in accordance with its requirements and specifications, in similarity to its predicate device. Consequently, the LightSheer Desire Light Laser System was found to perform as well as its predicate, to be as safe and effective for its intended use as its predicate, and is substantially equivalent to its predicate device without raising any new safety and/or effectiveness issues.

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.