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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 K252994
Device Name LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8)
Applicant
Guangdong Ace-Tec Co., Ltd.
#420, Jinxing Rd., Xixi Industrial Park, Liaobu Town
Dongguan,  CN 523400
Applicant Contact Fate Chen
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center,
# 3101-90 Qianhai Rd.
Shenzhen,  CN 518052
Correspondent Contact Tracy Che
Regulation Number878.4810
Classification Product Code
OHS  
Subsequent Product Code
OLP  
Date Received09/18/2025
Decision Date 12/08/2025
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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