# K103540: Psoria-Light

- Pathway: 510(k) (Traditional)
- Applicant: Psoria-Shield, Inc.
- Decided: Feb 10, 2011 after 70 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: 6 generations back to K885026 (1989). 16 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024020: Theralight UV120-2 Uva/Uvb Phototherapy System, Theralight, Inc. (2003) Summary page 1.
- K073659: Xtrac Ultra 2, Model AL10000, Photo Medex, Inc. (2008) Summary page 1.

## Most influential descendants
- K192411: Psoria-Shield AURORA (2020), 2 descendants of its own
- K254234: Phototherapy System (DUV-COMBO) (2026), 0 descendants of its own
- K230076: Enhanced AURORA™ Medical Diode System, and related accessories (2023), 0 descendants of its own

## Indications for use
The Psoria-Light Model PSI1000 is indicated for use in targeted PUVA photochemistry and UVB phototherapy for the treatment of skin conditions including psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis. In addition, the system UVB channel is indicated for the treatment of leukoderma.

Source page: https://510kreport.com/device/K103540
Methodology: https://510kreport.com/methodology