# K253871: Klär Lite (RCW-KL1000)

- Pathway: 510(k) (Traditional)
- Applicant: Radcliffe Watts, LLC
- Decided: Mar 4, 2026 after 90 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: 8 generations back to K885026 (1989). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170489: Skylit Phototherapy System, Skylit Medical (2017) Summary page 7.

## Indications for use
The Klar Lite is an Ultraviolet Light Emitting Medical Device. It is intended for use in localized phototherapeutic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leukoderma on all skin types (1-VI).

Source page: https://510kreport.com/device/K253871
Methodology: https://510kreport.com/methodology