# K192642: 308nm Excimer System

- Pathway: 510(k) (Traditional)
- Applicant: Chongqing Peninsula Medical Technology Co., Ltd.
- Decided: May 13, 2020 after 232 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: 19 generations back to K943450 (1995). 248 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 251 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173436: Luma Light System, Luma Therapeutics (2018) Summary page 4.
- K172273: 308nm Excimer System, Chongqing Peninsula Medical Technology Co., Ltd. (2018) Summary page 4.
- K191086: Exciplex, Clarteis (2019). Cleared while this submission was under review Summary page 5.

## Most influential descendants
- K200971: 308nm Excimer System (2020), 1 descendant of its own
- K242977: 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K) (2025), 0 descendants of its own

## Indications for use
The 308nm Excimer System (model: XECL-308E) is an Ultraviolet Light Emitting Medical Device. It is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma. It is to be used on intact skin only.

Source page: https://510kreport.com/device/K192642
Methodology: https://510kreport.com/methodology