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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 K230336
Device Name CurrentBody Skin™ Led Hair Regrowth(Model: MZ-07)
Applicant
Light Tree Ventures Europe B.V.
Laan van Ypenburg 108, 2497 GC, The Hague, The Netherlands
Hague,  NL
Applicant Contact Alain Dijkstra
Correspondent
Light Tree Ventures Europe B.V.
Laan van Ypenburg 108, 2497 GC, The Hague, The Netherlands
Hague,  NL
Correspondent Contact Alain Dijkstra
Regulation Number890.5500
Classification Product Code
OAP  
Date Received02/07/2023
Decision Date 04/05/2023
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
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