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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 K123435
Device Name IPL THERAPY SYSTEM
Applicant
BEIJING SINCOHEREN S&T DEVELOPMENT CO LTD
7TH FLOOR 982 CONGYUN ROAD, BAIYUN DISTRICT
GUANGZHOU, GUANGDONG,  CN 510420
Applicant Contact MIKE GU
Correspondent
BEIJING SINCOHEREN S&T DEVELOPMENT CO LTD
7TH FLOOR 982 CONGYUN ROAD, BAIYUN DISTRICT
GUANGZHOU, GUANGDONG,  CN 510420
Correspondent Contact MIKE GU
Regulation Number878.4810
Classification Product Code
ONF  
Date Received11/07/2012
Decision Date 02/11/2013
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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