# K100893: Cheveux Diode Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Sandstone Medical Technologies, LLC
- Decided: Jun 16, 2010 after 77 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 K003614 (2001). 1 ancestor in all.
8 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003614: Lightsheer Pulsed Diode Array Laser System, Coherent Star (2001) Summary page 1.

## Most influential descendants
- K120622: Palomar Vectus Laser (2012), 4 descendants of its own
- K193426: Elite iQ (2020), 1 descendant of its own
- K162765: Venus Velocity Diode Laser System (2017), 1 descendant of its own
- K123777: Multilaser System (2013), 1 descendant of its own
- K240396: Elite iQ PRO (M122K1) (2024), 0 descendants of its own

## Indications for use
The Cheveux Diode Laser System is indicated for: Hair Removal Permanent hair reduction Treatment of vascular lesions Treatment of benign pigmented lesions Treatment of Leg Veins Treatment for pseudofolliculitis barbae The Cheveux Laser System is intended for use on all skin types (Fitzpatrick Skin types I-VI) including tanned Skin

Source page: https://510kreport.com/device/K100893
Methodology: https://510kreport.com/methodology