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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 K252189
Device Name LED Light Therapy Mask (2311, 2344, 2457, 2458)
Applicant
Dongguan Yanxi Technology Co., Ltd.
Rm. 501, No 19, Guanglong Rd., Tianxin Village
Huangjiang Town
Dongguan,  CN 523763
Applicant Contact Xing Liang Lai
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center,
# 3101-90, Qianhai Rd.
Shenzhen,  CN 518082
Correspondent Contact Bing Huang
Regulation Number878.4810
Classification Product Code
OHS  
Subsequent Product Code
OLP  
Date Received07/14/2025
Decision Date 09/12/2025
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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