# K053628: Lightsheer Duet Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Lumenis, Inc.
- Decided: Apr 7, 2006 after 99 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
No predicates in its family tree.
351 later devices descend from it; 9 cite it directly.
0 of 352 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Lumenis, Inc. LightSheer® Pulsed Diode Array Laser System: named in the summary without a submission number
- (no number) AesThera Corporation AIP™ Intense Pulsed Light System: named in the summary without a submission number

## Most influential descendants
- K072564: Alma Lasers Harmony XL Multi-Application Platform (2008), 266 descendants of its own
- K083899: Revlite Q-Switched ND:Yag Laser System (2009), 198 descendants of its own
- K083848: Alma Lasers Soprano XL Multi-Application Platform (2009), 125 descendants of its own
- K102716: Modified Alma Lasers Family of Soprano XL Multi-Application Platmforms (2010), 124 descendants of its own
- K112031: Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with the Family of Soprano XL Multi-Application (2011), 118 descendants of its own

## Indications for use
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. LightSheer® Duet™ Laser Systems with LightSheer® ET™ Laser Handpiece is indicated for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia and other benign vascular lesions, and the treatment for pseudofolliculitis barbae. The LightSheer® Duet™ Laser System with LightSheer® ET™ Laser Handpiece is also indicated for hair removal, permanent hair reduction, and the treatment of benign pigmented lesions and leg veins. LightSheer® Duet™ Laser Systems with LightSheer® HS™ Laser Handpiece is indicated for the treatment of benign vascular and pigmented lesions, hair removal, and permanent hair reduction.

Source page: https://510kreport.com/device/K053628
Methodology: https://510kreport.com/methodology