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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 K252983
Device Name Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)
Applicant
Shenzhen Goodwind Technology Development Co., Ltd.
Rm. 801, Bldg. 1, Baolong Intelligent Manufacturing Park
# 34, Baotong Rd., Baolong Community, Longgang
Shenzhen,  CN 518116
Applicant Contact Ziming Yang
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center,
# 3101-90, Qianhai Rd.
Shenzhen,  CN 518082
Correspondent Contact Bing Huang
Regulation Number878.4810
Classification Product Code
OHS  
Date Received09/18/2025
Decision Date 12/17/2025
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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