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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 K093627
Device Name IPULSELIGHT IPL SYSTEM, MODELS HS 300C AND HS 650
Applicant
Shanghai Apolo Medical Technologies Co., Ltd.
49 Candle Wood Way
Buena Park,  CA  90621
Applicant Contact BRANDON CHOI
Correspondent
Shanghai Apolo Medical Technologies Co., Ltd.
49 Candle Wood Way
Buena Park,  CA  90621
Correspondent Contact BRANDON CHOI
Regulation Number878.4810
Classification Product Code
ONF  
Date Received11/23/2009
Decision Date 01/18/2011
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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