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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 K250966
Device Name CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)
Applicant
Shenzhen Kaiyan Medical Equipment Co., Ltd.
Bldg.#3 And Bldg.#5, 40th Of Fuxin St.,
Huaide Community Fuyong Town
Shenzhen,  CN 518103
Applicant Contact Dijkstra Alain
Correspondent
Shenzhen Kaiyan Medical Equipment Co., Ltd.
Bldg.#3 And Bldg.#5, 40th Of Fuxin St.,
Huaide Community Fuyong Town
Shenzhen,  CN 518103
Correspondent Contact Dijkstra Alain
Regulation Number878.4810
Classification Product Code
OHS  
Date Received03/31/2025
Decision Date 06/25/2025
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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