# K171702: Exciplex308nm

- Pathway: 510(k) (Traditional)
- Applicant: Clarteis
- Decided: Oct 13, 2017 after 127 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: 17 generations back to K943450 (1995). 232 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 238 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073066: 308 Dermatological Excimer System, Quantel Medical, Inc. (2007) Summary page 5.
- K150752: GME ExSys 308, Gme (German Medical Engineering) GmbH (2015) Summary page 5.
- K051428: Vtrac Excimer Lamp System, Photo Medex, Inc. (2005) Summary page 5.

## Most influential descendants
- 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
- K242977: 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K) (2025), 0 descendants of its own
- K221623: FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm (2023), 0 descendants of its own

## Indications for use
The Exciplex308nm is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma.

Source page: https://510kreport.com/device/K171702
Methodology: https://510kreport.com/methodology