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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 K131712
Device Name A-TONE IPL SYSTEM
Applicant
Ybk Investment, Inc.
1915 White Star Dr.
Diamond Bar,  CA  91765
Applicant Contact JOYCE BANG
Correspondent
Ybk Investment, Inc.
1915 White Star Dr.
Diamond Bar,  CA  91765
Correspondent Contact JOYCE BANG
Regulation Number878.4810
Classification Product Code
ONF  
Date Received06/11/2013
Decision Date 05/30/2014
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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