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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Over-The-Counter Powered Light Based Laser For Acne
510(k) Number K230720
Device Name LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001
Applicant
Light Tree Ventures Europe B.V.
Laan Van Ypenburg 108, 2497 Gc, The Hague, The Netherlands
Hague,  NL
Applicant Contact Kim Laurens
Correspondent
Light Tree Ventures Europe B.V.
Laan Van Ypenburg 108, 2497 Gc, The Hague, The Netherlands
Hague,  NL
Correspondent Contact Kim Laurens
Regulation Number878.4810
Classification Product Code
OLP  
Date Received03/16/2023
Decision Date 07/03/2023
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
Predetermined Change
Control Plan Authorized		 No
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