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510(k) K150409

Device
VIVACE Electrosurgical System
Applicant
Sung Hwan E&B Co.,Ltd
510(k) number
K150409
Product code
OUH  
Decision
Substantially Equivalent (SESE)
Decision date
2016-01-15
Date received
2015-02-18
Regulation
878.4400
Classification name
Skin Resurfacing Rf Applicator
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Sun Young Kang
Address
Sk Techno Bld Suite #502 ,16-4 Seongsu-Dong 1-Ga Seongdong-Gu KR 133710 133710

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OUH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K142833INTRAGenJeisys Medical, Inc.2015-06-04
K130501INTENSIFEndymed Medical, Ltd.2014-03-13
K120513GLOW BY ENDYMEDEndymed Medical, Ltd.2012-05-08
K101510FRACTIONAL SKIN RESURFACING (FSR) APPLICATOREndymed Medical, Ltd.2011-02-17

Legacy Summary#

summary

FDA Review#

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