# K191086: Exciplex

- Pathway: 510(k) (Traditional)
- Applicant: Clarteis
- Decided: Dec 11, 2019 after 231 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: 18 generations back to K943450 (1995). 233 ancestors in all.
4 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)
- K171702: Exciplex308nm, Clarteis (2017) Summary page 4.

## Most influential descendants
- 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 exciplex® is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma. The reusable polycarbonate/ABS reduction tips and reusable silicone masks are for use on intact skin only.

Source page: https://510kreport.com/device/K191086
Methodology: https://510kreport.com/methodology