VIVACE Electrosurgical System

Skin Resurfacing Rf Applicator

Sung Hwan E&B Co.,Ltd

The following data is part of a premarket notification filed by Sung Hwan E&b Co.,ltd with the FDA for Vivace Electrosurgical System.

Pre-market Notification Details

Device IDK150409
510k NumberK150409
Device Name:VIVACE Electrosurgical System
ClassificationSkin Resurfacing Rf Applicator
Applicant Sung Hwan E&B Co.,Ltd SK Techno Bld Suite #502 ,16-4 Seongsu-Dong 1-Ga Seongdong-gu,  KR 133710
ContactSun Young Kang
CorrespondentKachi Enyinna
510K Technology Group, LLC 263 Huntington Avenue, Suite #332 Boston,  MA  02115
Product CodeOUH  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-02-18
Decision Date2016-01-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08800017100326 K150409 000
08800017100234 K150409 000
08800017100722 K150409 000
08800017100715 K150409 000

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