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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Skin Resurfacing Rf Applicator
510(k) Number K150409
Device Name VIVACE Electrosurgical System
Applicant
Sung Hwan E&B Co.,Ltd
Sk Techno Bld Suite #502 ,16-4 Seongsu-Dong 1-Ga
Seongdong-Gu,  KR 133710
Applicant Contact Sun Young Kang
Correspondent
510K Technology Group, LLC
263 Huntington Ave., Suite 332
Boston,  MA  02115
Correspondent Contact Kachi Enyinna
Regulation Number878.4400
Classification Product Code
OUH  
Date Received02/18/2015
Decision Date 01/15/2016
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
Recalls CDRH Recalls
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