Manufacturer
Lumenis, Inc.LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity
Country / Region:Israel (IL)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K170179
- Device name
- LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity
- Company
- Lumenis, Inc.
- 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—
—
Not ingested
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—
Not ingested
LightSheer Desire Light Laser System
K170179 references 3 predicate/reference devices
Cited as predicate
8Primelase Excellence
MeDioStar
elysion-pro
Primelase Excellence
EpilME
Echo
MeDioStar
Diode Laser Therapy Systems (WLA-02)
8 submissions cite K170179 as a predicate
