# K202827: 308nm Excimer UV-light Skin Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Gsd Tech Co., Ltd.
- Decided: Dec 15, 2020 after 82 days
- Product code: FTC (Light, Ultraviolet, Dermatological)
- Device class: 2
- Regulation: 21 CFR 878.4630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K943450 (1995). 225 ancestors in all.
No later device cites it as a predicate yet.
0 of 226 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172273: 308nm Excimer System, Chongqing Peninsula Medical Technology Co., Ltd. (2018) Summary page 4.

## Indications for use
The 308nm Excimer UV-light Skin Therapy System is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only.

Source page: https://510kreport.com/device/K202827
Methodology: https://510kreport.com/methodology