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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name powered light based non-laser surgical instrument with thermal effect
510(k) Number K200746
Device Name IPL Treatment Systems
Applicant
Shanghai Apolo Medical Technology Co., Ltd.
4F, Building A, No.388, Yindu Road, Xuhui District
Shanghai,  CN 200231
Applicant Contact Felix Li
Correspondent
Shanghai Apolo Medical Technology Co., Ltd.
4F, Building A, No.388, Yindu Road, Xuhui District
Shanghai,  CN 200231
Correspondent Contact Felix Li
Regulation Number878.4810
Classification Product Code
ONF  
Date Received03/23/2020
Decision Date 05/15/2020
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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