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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 K241933
Device Name HIGHERDOSE Red and Infrared Light Mask (MK66-L)
Applicant
Shenzhen Kaiyan Medical Equipment Co., Ltd.
Bldg.#3 And Bldg.#5, 40th Of Fuxin St.
Huaide Community Fuyong Town Baoan District
Shenzhen,  CN 518103
Applicant Contact Alain Dijkstra
Correspondent
Shenzhen Kaiyan Medical Equipment Co., Ltd.
Bldg.#3 And Bldg.#5, 40th Of Fuxin St.
Huaide Community Fuyong Town Baoan District
Shenzhen,  CN 518103
Correspondent Contact Alain Dijkstra
Regulation Number878.4810
Classification Product Code
OHS  
Date Received07/02/2024
Decision Date 09/27/2024
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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