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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 K252096
Device Name Light Therapy Decollete Mask (1019135)
Applicant
Merchsource, LLC
7755 Irvine Center Dr. Suite 100
Irvine,  CA  92618
Applicant Contact Shirley Luo
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center, # 3101-90, Qia
Shenzhen,  CN 518052
Correspondent Contact Candice Qiu
Regulation Number878.4810
Classification Product Code
OHS  
Date Received07/03/2025
Decision Date 10/01/2025
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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