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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Ultraviolet, Dermatological
510(k) Number K253871
Device Name Klär Lite (RCW-KL1000)
Applicant
Radcliffe Watts, LLC
201 E 5th St.
Mansfield,  OH  44902
Applicant Contact Dan Smith
Correspondent
Radcliffe Watts, LLC
201 E 5th St.
Mansfield,  OH  44902
Correspondent Contact Dan Smith
Regulation Number878.4630
Classification Product Code
FTC  
Date Received12/04/2025
Decision Date 03/04/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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