# K150752: GME ExSys 308

- Pathway: 510(k) (Traditional)
- Applicant: Gme (German Medical Engineering) GmbH
- Decided: Jul 31, 2015 after 130 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: 16 generations back to K943450 (1995). 223 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 233 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090762: LEDA, Quantel Derma GmbH (2009) Summary page 5.

## Most influential descendants
- K172273: 308nm Excimer System (2018), 5 descendants of its own
- K171702: Exciplex308nm (2017), 5 descendants of its own
- K191086: Exciplex (2019), 4 descendants of its own
- K192642: 308nm Excimer System (2020), 2 descendants of its own
- K200971: 308nm Excimer System (2020), 1 descendant of its own

## Indications for use
The GME ExSys 308 System is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only.

Source page: https://510kreport.com/device/K150752
Methodology: https://510kreport.com/methodology