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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 K101901
Device Name IPL THERAPY SYSTEM
Applicant
Beijing Starlight Science & Technology Development
Suite 5d # 19 Lane 999
Zhongshan No 2 Rd.(S)
Shanghai Shanghai,  CN 200030
Applicant Contact Diana Hong
Correspondent
Beijing Starlight Science & Technology Development
Suite 5d # 19 Lane 999
Zhongshan No 2 Rd.(S)
Shanghai Shanghai,  CN 200030
Correspondent Contact Diana Hong
Regulation Number878.4810
Classification Product Code
ONF  
Date Received07/08/2010
Decision Date 03/08/2011
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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