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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name light based over the counter wrinkle reduction
510(k) Number K230124
Device Name LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001)
Applicant
Light Tree Ventures Europe B.V.
Laan van Ypenburg 108, 2497 GC, The Hague, The Netherlands
Hague,  NL 2500
Applicant Contact Alain Dijkstra
Correspondent
Light Tree Ventures Europe B.V.
Laan van Ypenburg 108, 2497 GC, The Hague, The Netherlands
Hague,  NL 2500
Correspondent Contact Alain Dijkstra
Regulation Number878.4810
Classification Product Code
OHS  
Subsequent Product Code
OLP  
Date Received01/17/2023
Decision Date 03/15/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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