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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 K250830
Device Name LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK)
Applicant
Shenzhen Sungrow Led Technology Co., Ltd.
3f 2# Factory Bidg (Phase I) , Bangkai Sci & Tech Lnd Park
Guangming High-Tech Lnd Park
Shenzhen,  CN 518000
Applicant Contact Yafen Zhang
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center, # 3101-90
Qianhai Rd.
Shenzhen,  CN 518052
Correspondent Contact Bing Huang
Regulation Number878.4810
Classification Product Code
OHS  
Subsequent Product Code
OLP  
Date Received03/19/2025
Decision Date 06/09/2025
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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