# K230076: Enhanced AURORA™ Medical Diode System, and related accessories

- Pathway: 510(k) (Traditional)
- Applicant: Psoria-Shield, Inc.
- Decided: Mar 8, 2023 after 57 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.
- K073659: Xtrac Ultra 2, Model AL10000, Photo Medex, Inc. (2008) Summary page 5.

## Indications for use
The Enhanced AURORA™ Medical Diode system and related accessories 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/K230076
Methodology: https://510kreport.com/methodology