LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity

Lumenis, Inc.

Country / region:Israel (IL)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Israel (IL)

Product code

GEX
21 CFR 878.4810

Predicate devices

3

Cited as predicate

8

Device details

FDA 510(k) registration fields

K number
K170179
Device name
LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity
Country / region
Israel(IL)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2017-01-19
Decision date
2017-09-18
Submission type
Traditional
Technology type
Diode(AI inferred)
Clinical applications
Hair removalSurgical cutting
Primary application
Hair removal
Classification source
AI classified

Indications for Use

The LightSheer Family of Pulsed Diode Array Laser Systems (LightSheer Duet, LightSheer Desire, LightSheer Desire Light and LightSheer Infinity) is indicated for use in surgical, aesthetic, and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology. The systems are 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, hemangiomas, 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*

The LightSheer Desire System with LightSheer ET/XC 805nm Laser Handpieces are intended for:
• Treatment of benign vascular lesions, including angiomas, hemangiomas, 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:
• 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

The LightSheer Desire Light System with LightSheer ET/XC 805nm Laser Handpieces are intended for:
• Treatment of benign vascular lesions, including angiomas, hemangiomas, 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 1060nm Handpiece 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

The LightSheer Inf

Intended Use

The LightSheer Family of Pulsed Diode Array Laser Systems (LightSheer Duet, LightSheer Desire, LightSheer Desire Light and LightSheer Infinity) is indicated for use in surgical, aesthetic, and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology. The systems are intended for use on all skin types (Fitzpatrick skin types I – VI), including tanned skin. Specific indications include treatment of benign vascular lesions, pseudofolliculitis barbae (PFB), hair removal, permanent hair reduction, and treatment of benign pigmented lesions.

Device Description

The Lumenis LightSheer Family of Pulse Diode Array Laser Systems consists of four laser consoles: LightSheer Duet, LightSheer Infinity, LightSheer Desire, and LightSheer Desire Light. The laser consoles provide a graphical user interface and software for control of the system, electronics to control and power the accessories, handpiece connection ports, a vacuum pump (most models), and a cooling system. Handpieces can be categorized into high speed (HS) Handpieces with vacuum technology or ET, XC, and LR Handpieces with cooling technology, available with different sized tips. The handpieces deliver pulsed diode laser light with wavelengths ranging from 790 - 950nm (805nm nominal) or 1040-1080nm (1060nm nominal), and are compatible with multiple systems in the LightSheer Family.

Summary parsed at:2026-06-01 05:59:30 UTC

Predicate devices

3

K170179 references 3 predicate/reference devices

Cited as predicate

8