# K061295: Versaclear Skin Therapy System, Model 100

- Pathway: 510(k) (Special)
- Applicant: Theralight, Inc.
- Decided: May 25, 2006 after 16 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: 2 generations back to K828654 (1983). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050695: Flex Controlled Phototherapy Equipment, Daavlin Distributing Co. (2005) Summary page 1.

## Indications for use
The VersaClear Skin Therapy System UVA (350nm) Light Module is indicated for individuals who require specific ultraviolet radiation therapy for diagnosed skin disorders.

Source page: https://510kreport.com/device/K061295
Methodology: https://510kreport.com/methodology