510(k) K253871
K253871 is an FDA 510(k) premarket notification submitted by Radcliffe Watts, LLC for the device "Klär Lite (RCW-KL1000)". The FDA issued a decision of Substantially Equivalent on March 4, 2026. The device falls under product code FTC (Light, Ultraviolet, Dermatological), a Class II device regulated under 21 CFR 878.4630.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 4, 2026
- Date Received
- December 4, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light, Ultraviolet, Dermatological
- Device Class
- Class II
- Regulation Number
- 878.4630
- Review Panel
- SU
- Submission Type