# K134009: UV Biotek Single Panel, UV Biotek Multi-Directional

- Pathway: 510(k) (Traditional)
- Applicant: Medtek Lighting
- Decided: Oct 15, 2014 after 289 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: 3 generations back to K828654 (1983). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111049: Mobile Versa Light, Medtek Lighting Corp (2012) Summary page 5.

## Indications for use
The UV Biotek Multi-Directional device is for individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders and is used for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I - VI). The UV Biotek Single Panel Unit device models 100B/80B/60B/40B are for individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders and is used for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I - VI)

Source page: https://510kreport.com/device/K134009
Methodology: https://510kreport.com/methodology