# K170179: LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity

- Pathway: 510(k) (Traditional)
- Applicant: Lumenis, Ltd.
- Decided: Sep 18, 2017 after 242 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K910422 (1992). 106 ancestors in all.
14 later devices descend from it; 7 cite it directly.
0 of 121 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053628: Lightsheer Duet Laser System, Lumenis, Inc. (2006) Summary page 6.
- K151947: LightSheer Desire Light Laser System, Lumenis, Ltd. (2015) Summary page 6.
- K133319: ET Lightsheer 1060, High Speed Lightsheer 1060, Lumenis, Ltd. (2014) Summary page 6.

## Most influential descendants
- K191321: Primelase Excellence (2019), 8 descendants of its own
- K192483: MeDioStar (2020), 3 descendants of its own
- K193367: elysion-pro (2020), 3 descendants of its own
- K201594: Primelase Excellence (2020), 2 descendants of its own
- K241656: Eneka Selectif (2024), 1 descendant of its own

## 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, 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* 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, 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 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 Ligth 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 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 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 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 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.

Source page: https://510kreport.com/device/K170179
Methodology: https://510kreport.com/methodology