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510(k) K130283

Device
EVRF SYSTEM
Applicant
F CARE SYSTEMS NV
510(k) number
K130283
Product code
ONQ  
Decision
Substantially Equivalent (SESE)
Decision date
2013-03-07
Date received
2013-02-05
Regulation
878.4400
Classification name
Electrosurgical Coagulation For Aesthetic
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
Yes

Applicant Contact#

Contact
E. J SMITH
Address
1468 Harwell Ave. Crofton MD US 21114 21114

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code ONQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K210077MED RF 4000F Care Systems USA, LLC2021-12-17
K112334VEIN-GOGH INSTRUMENTRefine USA, LLC2012-05-08
K083352VEINWAVE, TC3000Newlands Clinical Trials, Ltd.2009-06-12

Legacy Summary#

summary

FDA Review#

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