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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 Rd.
Baiyun District
Guangzhou, Guangdong,  CN 510420
Applicant Contact MIKE GU
Correspondent
Beijing Sincoheren S&T Development Co, Ltd.
7th Floor, 982 Congyun Rd.
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
Predetermined Change
Control Plan Authorized		 No
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