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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 hair removal
510(k) Number K222316
Device Name IPL Hair Removal Device
Applicant
Shenzhen Goodwind Technology Development CO., LTD
4th&5Th Floor,2nd Part Of Building A1,
Yinlong Industrial Park, Gate 292, Longgang Section Of Sh
Shenzhen,  CN 518116
Applicant Contact Ziming Yang
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Shenzhen,  CN 518000
Correspondent Contact Rain Yip
Regulation Number878.4810
Classification Product Code
OHT  
Date Received08/02/2022
Decision Date 09/28/2022
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
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