# K082247: Evis MD Platinum Red Light Therapy

- Pathway: 510(k) (Traditional)
- Applicant: Ageless Beauty Corporation
- Decided: Oct 8, 2008 after 61 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K943450 (1995). 83 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030426: Omnilux Red, Photo Therapeutics Limited (2003) Summary page 1.

## Most influential descendants
- K140386: Lumina 24 (2015), 0 descendants of its own

## Indications for use
The Evis MD Platinum Red Light Therapy device is intended to provide light to the body. Generally indicated to dermatology use for the treatment of superficial, benign vascular and pigmented lesions "such as but not limited to solar lentigines, sun spots, liver spots and age spots".

Source page: https://510kreport.com/device/K082247
Methodology: https://510kreport.com/methodology