# K242977: 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)

- Pathway: 510(k) (Traditional)
- Applicant: Xuzhou Kernel Medical Equipment Co., Ltd.
- Decided: Feb 6, 2025 after 133 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: 21 generations back to K943450 (1995). 250 ancestors in all.
No later device cites it as a predicate yet.
0 of 251 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200971: 308nm Excimer System, Xuzhou Kernel Medical Equipment Co., Ltd. (2020) Summary page 5.

## Indications for use
308nm Excimer Phototherapy Device 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/K242977
Methodology: https://510kreport.com/methodology