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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 K261496
Device Name LED Light Therapy Masks (PE748, PE749, PE756)
Applicant
Duplex International Trading Limited
B1, 10/F, Block 2, Golden Dragon Ind Center, 162-170 Tai Lin
Hongkong,  CN
Applicant Contact JunYi Xing
Correspondent
Duplex International Trading Limited
B1, 10/F, Block 2, Golden Dragon Ind Center, 162-170 Tai Lin
Hongkong,  CN
Correspondent Contact JunYi Xing
Regulation Number878.4810
Classification Product Code
OHS  
Subsequent Product Code
OLP  
Date Received05/06/2026
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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