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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 K261851
Device Name LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED Light Therapy Mask (JML5, JML5+JML7); LED Light Therapy Mask (JML6, JML6+JML8); LED Light Therapy Mask ( JML9, JML9+JML10)
Applicant
Shenzhen Qianyu Technology Co., Ltd.
Rm. 601, Han'S Technology Center. #9988, Shennanavenue, Mali
Shenzhen,  CN 518000
Applicant Contact Li Guoyang
Correspondent
Shenzhen Qianyu Technology Co., Ltd.
Rm. 601, Han'S Technology Center. #9988, Shennanavenue, Mali
Shenzhen,  CN 518000
Correspondent Contact Li Guoyang
Regulation Number878.4810
Classification Product Code
OHS  
Subsequent Product Code
OLP  
Date Received06/03/2026
Decision Date 08/04/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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