# K183122: 810nm Diode Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd
- Decided: Aug 25, 2019 after 289 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: 2 generations back to K003614 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100893: Cheveux Diode Laser System, Sandstone Medical Technologies, LLC (2010) Summary page 4.

## Indications for use
The Cheveux Diode Laser System is indicated for: Hair Removal Permanent hair reduction Treatment of benign 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/K183122
Methodology: https://510kreport.com/methodology