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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 K102857
Device Name AHWON'S IPL SYSTEM
Applicant
Ahwon Medi Instrument Co., Ltd.
111 Ellison St.
Paterson,  NJ  07505
Applicant Contact YOUNG CHI
Correspondent
Ahwon Medi Instrument Co., Ltd.
111 Ellison St.
Paterson,  NJ  07505
Correspondent Contact YOUNG CHI
Regulation Number878.4810
Classification Product Code
ONF  
Date Received09/29/2010
Decision Date 01/14/2011
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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