# K151947: LightSheer Desire Light Laser System

- Pathway: 510(k) (Special)
- Applicant: Lumenis, Ltd.
- Decided: Aug 12, 2015 after 28 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: 1 generation back to K053628 (2006). 1 ancestor in all.
27 later devices descend from it; 4 cite it directly.
0 of 29 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 4.

## Most influential descendants
- K170738: InMode Diolaze XL (2017), 15 descendants of its own
- K170179: LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity (2017), 14 descendants of its own
- K180719: InMode Diolaze System (2018), 13 descendants of its own
- K191321: Primelase Excellence (2019), 8 descendants of its own
- K192483: MeDioStar (2020), 3 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K151947
Methodology: https://510kreport.com/methodology