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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 K251667
Device Name LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)
Applicant
Shenzhen Liyoutong Technology Co., Ltd.
705,7th Floor ,Bldg. H,Bantian International Ctr., #5 Huanch
South Rd., Ma'An Tang Community, Bantian St., Longgang Dist.
Shenzhen,  CN
Applicant Contact Zhenwen Lai
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center, # 3101-90, Qia
Shenzhen,  CN 518052
Correspondent Contact Riley Chen
Regulation Number878.4810
Classification Product Code
OHS  
Subsequent Product Code
OLP  
Date Received05/30/2025
Decision Date 08/07/2025
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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