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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Comb, Hair
510(k) Number K253349
Device Name Hair Regrowth Cap (Model: T-119-HRC)
Applicant
Light Tree Ventures Europe B.V.
Laan Van Ypenburg 108
Den Haag,  NL 2497 GC
Applicant Contact Kim Markwat
Correspondent
Light Tree Ventures Europe B.V.
Laan Van Ypenburg 108
Den Haag,  NL 2497 GC
Correspondent Contact Kim Markwat
Regulation Number890.5500
Classification Product Code
OAP  
Date Received09/30/2025
Decision Date 12/24/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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