# K244022: 308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)

- Pathway: 510(k) (Traditional)
- Applicant: Boston Aesthetics, Inc.
- Decided: Mar 13, 2025 after 76 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 5.

## Indications for use
The 308nm UV Phototherapy System is intended to be used for the treatment of psoriasis, vitiligo, seborrheic dermatitis, atopic dermatitis, and leukoderma. It is used on intact skin only.

Source page: https://510kreport.com/device/K244022
Methodology: https://510kreport.com/methodology