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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 K221775
Device Name LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)
Applicant
Light Tree Ventures Europe B.V.
Laan Van Ypenburg 108
Den Haag,  NL 2497 GC
Applicant Contact Kim Laurens
Correspondent
Shenzhen Kaiyan Medical Equipment Co., Ltd.
Bldg. 3, #40, Fuxin St., Huaide Community,
Fuyong Town, Baoan District
Shenzhen,  CN 518103
Correspondent Contact Alain Dijkstra
Regulation Number878.4810
Classification Product Code
OHS  
Subsequent Product Code
OLP  
Date Received06/21/2022
Decision Date 12/20/2022
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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