# K254234: Phototherapy System (DUV-COMBO)

- Pathway: 510(k) (Traditional)
- Applicant: Choyang Medics Co., Ltd.
- Decided: May 1, 2026 after 123 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: 8 generations back to K885026 (1989). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192411: Psoria-Shield AURORA, Psoria-Shield (2020) Summary page 5.

## Indications for use
The DUV-COMBO Phototherapy System is indicated for use in targeted PUVA photochemistry and UVB phototherapy to treat skin conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis. Additionally, its UVB channel is indicated for treating leukoderma.

Source page: https://510kreport.com/device/K254234
Methodology: https://510kreport.com/methodology