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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 K252308
Device Name LED Beauty Mask (RLBXX)
Applicant
Atop Lighting Co., Ltd.
4th. Floor, Bldg. C, # 3, Jian'An Rd.
Tangwei Community, Fuhai St., Baoan District
Shenzhen City,  CN 518110
Applicant Contact Tse Adrian
Correspondent
Atop Lighting Co., Ltd.
4th. Floor, Bldg. C, # 3, Jian'An Rd.
Tangwei Community, Fuhai St., Baoan District
Shenzhen City,  CN 518110
Correspondent Contact Tse Adrian
Regulation Number878.4810
Classification Product Code
OHS  
Date Received07/24/2025
Decision Date 11/13/2025
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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