The LightSheer Family of Pulsed Diode Array Laser Systems (LightSheer Desire, LightSheer Desire Light and LightSheer Infinity) is indicated for use in surgical, aesthetic applications in the medical specialties of general and plastic surgery, and dermatology. The LightSheer Family of Pulsed Diode Array Laser Systems is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.

Specific indications for each system and handpiece combination are listed in the document and include:

Treatment of benign vascular lesions, including angiomas, telangiectasia and other benign vascular lesions and leg veins
Treatment of pseudofolliculitis barbae (PFB)
Hair removal, permanent hair reduction*
Treatment of benign pigmented lesions, including age spots, solar lentigines, cafe-au-lait spots, nevi of Ota/Ito, melasma, Becker's nevi and other benign pigmented lesions
Treatment of wrinkles

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

Device Description

The Lumenis LightSheer Family of Pulse Diode Array Laser Systems consists of four laser consoles that can be used with up to four different types of handpieces. The four laser consoles are: LightSheer Duet, LightSheer Infinity, LightSheer Desire, and LightSheer Desire Light. The laser consoles provide (1) a graphical user interface and software for control of the system, (2) the needed electronics to control and power the accessories, (3) handpiece connection port(s), (4) a vacuum pump (most models) and (5) cooling system.

Handpieces can be divided into two categories, depending on the technology applied to the skin during treatment: high speed (HS) Handpieces with vacuum technology (HIT™) or ET, XC and LR Handpieces with cooling technology (ChillTip), available with different sized tips. Some handpieces are universal, supporting different ChillTip sizes within a single handpiece. In addition, these handpieces either deliver pulsed diode laser light with wavelengths ranging from 790 - 950nm (805nm nominal) or 1040-1080nm (1060nm nominal), depending on the diode array type. The same LightSheer Handpieces are compatible with multiple systems (such as the LightSheer Duet, LightSheer Infinity, LightSheer Desire, and LightSheer Desire Light), in which case they differ only in terms of the mechanical connection to the console.

AI/ML Overview

The provided text describes a 510(k) submission for the Lumenis LightSheer Family of Pulsed Diode Array Laser Systems. The purpose of the submission is to add 1060nm handpieces to the LightSheer Desire and LightSheer Desire Light Systems, which were previously cleared for use with other systems in the LightSheer Family. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a specific study proving those criteria are met for the device's indications for use.

Therefore, the specific information requested in the prompt regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available within this document. The document primarily details regulatory compliance and safety testing concerning substantial equivalence.

However, I can extract information related to the performance testing that was conducted to support the substantial equivalence claim, which can be interpreted as demonstrating the device meets general safety and effectiveness requirements.

Acceptance Criteria and Reported Device Performance (General Safety and Effectiveness)

While explicit "acceptance criteria" in the format of specific clinical metrics are not provided, the document states performance testing was conducted to verify that the modifications did not raise "different questions of safety and effectiveness." The reported performance is that the device conforms to relevant safety and performance standards.

Acceptance Criteria Category	Reported Device Performance (as stated in the document)
Risk Analysis	Conforms to ISO 14971
Electrical Safety	Conforms to IEC 60601-1 (Medical electrical equipment Part 1: General requirements for basic safety and essential performance)
Electromagnetic Compatibility (EMC)	Conforms to IEC 60601-1-2 (Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - requirements and tests)
Laser Safety	Conforms to IEC 60825-1 (Safety of laser products - Part 1: Equipment classification and requirements)
Medical Laser Equipment Safety	Conforms to IEC 60601-2-22 (Medical electrical equipment - part 2: particular requirements for the safety of diagnostic and therapeutic laser equipment)
Software Performance	Software verification and validation performed

Information Not Available in the Document:

Sample size used for the test set and the data provenance: The document does not describe a clinical "test set" with patient data or its provenance for demonstrating the device's clinical efficacy against specific acceptance criteria.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as detailed clinical testing with expert-established ground truth is not described.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, and 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-assisted diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not explicitly stated beyond conformance to engineering and safety standards. There is no mention of expert consensus, pathology, or outcomes data for a clinical ground truth.
The sample size for the training set: Not applicable, as this is a laser and not a machine learning algorithm.
How the ground truth for the training set was established: Not applicable.

Summary of Study Described:

The study referenced in the document is a regulatory "performance testing" conducted internally by Lumenis to demonstrate that the modifications (adding 1060nm handpieces) to the LightSheer Desire and LightSheer Desire Light Systems, and other system modifications, do not raise new questions of safety or effectiveness. This testing primarily involved:

Risk Analysis: Performed according to ISO 14971.
Electrical and Laser Safety and Electromagnetic Compatibility (EMC) Testing: Conformance to international standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22).
Software Verification and Validation: Ensured the software functions as intended and meets requirements.

The document asserts that based on these activities, the device is "substantially equivalent" to its legally marketed predicates. This type of submission relies on demonstrating that the new device or modification is as safe and effective as a predicate device, rather than proving a set of specific clinical performance claims with clinical trials against acceptance criteria.

Summary

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

September 18, 2017

Lumenis Ltd. Amaya Levie Head Of RA Surgical Bu 6 Hakidma Street Po Box 240 Yokneam, 2069204 IL

Re: K170179

Trade/Device Name: Lightsheer Desire: Lightsheer Desire Light: Lightsheer Duet; Lightsheer Infinity 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: August 17, 2017 Received: August 21, 2017

Dear Amaya Levie:

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 Actinclude 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

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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 (DICE) 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. 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

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 (DICE) 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.

Jennifer R. Stevenson -S3

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

Enclosure

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Indications for Use

510(k) Number (if known) K170179

Device Name

The LightSheer Family of Pulsed Diode Array Laser Systems (LightSheer Desire, LightSheer Desire Light and LightSheer Infinity)

Indications for Use (Describe)

LightSheer Duet:

The LightSheer Duet System is indicated for use in surgical, aesthetic applications in the medical specialties of general and plastic surgery, and dermatology. The LightSheer Duet System is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.

The LightSheer Duet System with LightSheer ET 805nm Laser Handpiece is intended for:

· Treatment of benign vascular lesions, including angiomas, telangiectasia and other benign vascular lesions and leg veins

· Treatment of pseudofolliculitis barbae (PFB)
· Hair removal, permanent hair reduction*
· Treatment of benign pigmented lesions

The LightSheer Duet System with LightSheer HS 805nm Laser Handpiece is intended for:

· Treatment of benign vascular lesions
· Treatment of benign pigmented lesions
· Hair removal, and permanent hair reduction*

LightSheer Desire:

The LightSheer Desire System is indicated for use in surgical, aesthetic applications in the medical specialties of general and plastic surgery, and dermatology. The LightSheer Desire System is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.

The LightSheer Desire System with LightSheer ET/XC 805nm Laser Handpieces are intended for:

· Treatment of benign vascular lesions, including angiomas, telangiectasia and other benign vascular lesions and leg veins

· Treatment of pseudofolliculitis barbae (PFB)
· Hair removal, permanent hair reduction *
Treatment of benign pigmented lesions

The LightSheer Desire System with LightSheer HS 805nm Laser Handpiece is intended for:

· Treatment of benign vascular lesions
· Treatment of benign pigmented lesions
· Hair removal, and permanent hair reduction*

The LightSheer Desire System with LightSheer ET/XC 1060mm and LightSheer HS 1060mm Handpieces are intended for: · Treatment of benign vascular lesions, including angiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions

· Hair removal, permanent hair reduction*

· Treatment for Pseudofolliculitis Barbae (PFB)
· Treatment of benign pigmented lesions, including age spots, solar lentigines, cafe-au-lait spots, nevi of Ota/Ito,
melasma, Becker's nevi and other benign pigmented lesions

· Treatment of wrinkles

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LightSheer Desire Light:

The LightSheer Desire Light System is indicated for use in surgical, aesthetic, and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology. The Light System is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.

The LightSheer Desire Ligth System with LightSheer ET/XC 805nm Laser Handpieces are intended for:

· Treatment of benign vascular lesions, including angiomas, telangiectasia and other benign vascular lesions and leg veins

· Treatment of pseudofolliculitis barbae (PFB)

· Hair removal, permanent hair reduction*

· Treatment of benign pigmented lesions

The LightSheer Desire Light System with LightSheer ET/XC 1060mm Handpiece is intended for:

· Treatment of benign vascular lesions, including angiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions.

· Hair removal, permanent hair reduction*

· Treatment for Pseudofolliculitis Barbae (PFB)

· Treatment of benign pigmented lesions, including age spots, solar lentigines, cafe-au-lait spots, nevi of Ota/Ito,

melasma. Becker's nevi and other benign pigmented lesions

· Treatment of wrinkles

LightSheer Infinity:

The LightSheer Infinity System is indicated for use in surgical, aesthetic applications in the medical specialties of general and plastic surgery, and dermatology. The LightSheer Infinity System is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.

The LightSheer Infinity System with LightSheer ET/LR 805nm Laser Handpieces is intended for:

· Treatment of benign vascular lesions, including angiomas, telangiectasia and other benign vascular lesions and leg veins

· Treatment of pseudofolliculitis barbae (PFB)

· Hair removal, permanent hair reduction*

· Treatment of benign pigmented lesions

The LightSheer Infinity System with LightSheer HS 805nm Laser Handpiece is intended for:

· Treatment of benign vascular lesions
· Treatment of benign pigmented lesions

· Hair removal, and permanent hair reduction*

The LightSheer Infinity System with LightSheer ET/LR 1060mm and LightSheer HS 1060nm Handpieces is intended for: · Treatment of benign vascular lesions, including angiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions.

· Hair removal, permanent hair reduction

· Treatment for Pseudofolliculitis Barbae (PFB)

· Treatment of benign pigmented lesions, including age spots, solar lentigines, cafe-au-lait spots, nevi of Ota/Ito,

melasma, Becker's nevi and other benign pigmented lesions

• Treatment of wrinkles

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

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

ال Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY ULumenis®

Lumenis LightSheer Family of Diode Pulsed Array Laser Systems

Applicant Name:	Lumenis Ltd.
	6 Hakidma Street PO Box 240
	Yokneam Industrial Park,
	Yokneam 2069204, Israel
	Tel: +972-4-9599000
	Fax: +972-4-9599046
Contact Person:	Amaya De Levie
	Lumenis Ltd.
	6 Hakidma Street PO Box 240
	Yokneam Industrial Park,
	Yokneam 2069204, Israel
	Tel: +972-4-9599119
	amaya.de-levie@lumenis.com
Date Prepared:	September 14, 2017
Trade Name:	Lumenis LightSheer Family of Diode Pulsed Array Laser Systems
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:	K053628 Lumenis LightSheer Duet Light Laser SystemK151947 Lumenis LightSheer Desire Light Laser SystemK133319 LightSheer HS and ET 1060nm HPs for Duet

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Indications for Use:

LightSheer Duet:

The LightSheer Duet System is indicated for use in surgical, aesthetic, and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology. The LightSheer Duet System is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.

The LightSheer Duet System with LightSheer ET 805nm Laser Handpiece is intended for: -
- · Treatment of benign vascular lesions, including angiomas, telangiectasia and other benign vascular lesions and leg veins
- · Treatment of pseudofolliculitis barbae (PFB)
- · Hair removal, permanent hair reduction*
- · Treatment of benign pigmented lesions
The LightSheer Duet System with LightSheer HS 805nm Laser Handpiece is intended for: —
- · Treatment of benign vascular lesions
- · Treatment of benign pigmented lesions
- · Hair removal, and permanent hair reduction*

LightSheer Desire:

The LightSheer Desire System is indicated for use in surgical, aesthetic, and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology. The LightSheer Desire System is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.

-The LightSheer Desire System with LightSheer ET/XC 805nm Laser Handpieces are intended for:
- · Treatment of benign vascular lesions, including angiomas, telangiectasia and other benign vascular lesions and leg veins
- · Treatment of pseudofolliculitis barbae (PFB)
- · Hair removal, permanent hair reduction*
- · Treatment of benign pigmented lesions
। The LightSheer Desire System with LightSheer HS 805nm Laser Handpiece is intended for:
- · Treatment of benign vascular lesions
- · Treatment of benign pigmented lesions
- · Hair removal, and permanent hair reduction*
The LightSheer Desire System with LightSheer ET/XC 1060nm and LightSheer HS 1060nm — Handpieces are intended for:

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· Treatment of benign vascular lesions, including angiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions
· Hair removal, permanent hair reduction*
· Treatment for Pseudofolliculitis Barbae (PFB)
· Treatment of benign pigmented lesions, including age spots, solar lentigines, cafe-au-lait spots, nevi of Ota/Ito, melasma, Becker's nevi and other benign pigmented lesions
· Treatment of wrinkles

LightSheer Desire Light:

The LightSheer Desire Light System is indicated for use in surgical, aesthetic, and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology. The LightSheer Desire Light System is intended for use on all skin types (Fitzpatrick skin types I -VI), including tanned skin.

The LightSheer Desire Light System with LightSheer ET/XC 805nm Laser Handpieces are l intended for:
- · Treatment of benign vascular lesions, including angiomas, telangjectasia and other benign vascular lesions and leg veins
- · Treatment of pseudofolliculitis barbae (PFB)
- · Hair removal, permanent hair reduction*
- · Treatment of benign pigmented lesions
। The LightSheer Desire Light System with LightSheer ET/XC 1060nm Handpiece is intended for:

· Treatment of benign vascular lesions, including angiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions.

· Hair removal, permanent hair reduction*
· Treatment for Pseudofolliculitis Barbae (PFB)
· Treatment of benign pigmented lesions, including age spots, solar lentigines, cafe-au-lait spots, nevi of Ota/Ito, melasma, Becker's nevi and other benign pigmented lesions
Treatment of wrinkles

LightSheer Infinity:

The LightSheer Infinity System is indicated for use in surgical, aesthetic, and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology. The LightSheer Infinity System is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.

The LightSheer Infinity System with LightSheer ET/LR 805nm Laser Handpieces is intended l for:

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Treatment of benign vascular lesions, including angiomas, telangiectasia and other benign vascular lesions and leg veins
· Treatment of pseudofolliculitis barbae (PFB)
· Hair removal. permanent hair reduction*
· Treatment of benign pigmented lesions
The LightSheer Infinity System with LightSheer HS 805nm Laser Handpiece is intended for: l
- · Treatment of benign vascular and pigmented lesions
- Hair removal, and permanent hair reduction* .
l The LightSheer Infinity System with LightSheer ET/LR 1060nm and LightSheer HS 1060nm Handpieces is intended for:
- · Treatment of benign vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions.
- · Hair removal, permanent hair reduction
- · Treatment for Pseudofolliculitis Barbae (PFB)
- · Treatment of benign pigmented lesions, including age spots, solar lentigines, cafe-au-lait spots, nevi of Ota/Ito, melasma, Becker's nevi and other benign pigmented lesions
- Treatment of wrinkles

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

Device Description:

The Lumenis LightSheer Family of Pulse Diode Array Laser Systems consists of four laser consoles that can be used with up to four different types of handpieces. TThe four laser consoles are: LightSheer Duet, LightSheer Infinity, LightSheer Desire, and LightSheer Desire Light. The laser consoles provide (1) a graphical user interface and software for control of the system. (2) the needed electronics to control and power the accessories. (3) handpiece connection port(s), (4) a vacuum pump (most models) and (5) cooling system.

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Reason for Submission:

The purpose of this 510(k) is to add the 1060nm handpieces to the LightSheer Desire and LightSheer Desire Light Systems. These handpieces have been previously cleared for use with other systems in the LightSheer Family of Pulse Diode Array Laser Systems. For completeness, this submission also includes a description of all four systems in the LightSheer Family of Pulsed Diode Array Laser Systems.

Substantial Equivalence:

The intended use and indications for use of the modified LightSheer Desire Laser and LightSheer Desire Light are identical to the intended use and indications for use of its predicate device LightSheer Duet. In addition, the same technological characteristics and principles of operation apply for these systems. The modifications introduced to the subject LightSheer Desire Laser and LightSheer Desire Light involve adding compatibility to LightSheer1060nm Handpieces that have been previously been cleared for use with the LightSheer Duet System. In addition, there have also been some modifications made to the systems since their last clearance. These modifications have undergone a contemporaneous regulatory analysis that concluded that the cumulative modifications could not significantly affect safety or effectiveness. Performance testing was also conducted in order to demonstrate the performance of the modified LightSheer Family of Pulsed Diode Array Laser Systems and to verify that no different questions of safety and effectiveness have been raised due to the modifications introduced. The following activities were performed:

Risk analysis per ISO 14971. .
. Electrical and laser safety and electromagnetic compatibility testing as required to conform to performance standards as follows:
- o 60601-1: Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- 60601-1-2: Medical electrical equipment Part 1-2: General requirements for o basic safety and essential performance- Collateral standard: Electromagnetic compatibility- requirements and tests
- 60825-1: Safety of laser products -Part 1: Equipment classification and o requirements
- 60601-2-22: Medical electrical equipment- part 2: particular requirements for the o safety of diagnostic and therapeutic laser equipment.
Software verification and validation ●

Consequently, it is Lumenis' belief that the LightSheer Family of Pulsed Diode Array Laser Systems is substantially equivalent to its legally marketed predicates.

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.