# K082232: Evis MD Plantium Blue

- Pathway: 510(k) (Traditional)
- Applicant: Ageless Beauty Corporation
- Decided: Oct 15, 2008 after 69 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: 2 generations back to K031805 (2003). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070185: Tanda Skincare System, PLC-001, Tanda Blue, 414-001, Tanda Red, 660-001, Pharos Life Corporation (2007) Summary page 1.

## Most influential descendants
- K132838: Nutra Light Blue (2014), 2 descendants of its own
- K162371: Pulsaderm ACE-All Blue (2016), 0 descendants of its own
- K150370: Nutra Light Advanced (2015), 0 descendants of its own

## Indications for use
The Evis MD Platinum Blue Light Therapy device is intended to provide light to the body. Generally indicated to treat dermatological conditions and specifically indicated to treat mild to moderate inflammatory acne vulgaris.

Source page: https://510kreport.com/device/K082232
Methodology: https://510kreport.com/methodology