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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 K260150
Device Name LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)
Applicant
NOOANCE
22 Rue Beaujon
Paris,  FR 75008
Applicant Contact Carole Amar
Correspondent
Shenzhen Kaiyan Medical Equipment Co., Ltd.
Bldg.#3 And Bldg.#5, 40th Of Fuxin St.
Huaide Community, Fuyong Town, Baoan District, Shenzhen
Shenzhen,  CN
Correspondent Contact Anna He
Regulation Number878.4810
Classification Product Code
OHS  
Date Received01/20/2026
Decision Date 04/22/2026
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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