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510(k) K210077

Device
MED RF 4000
Applicant
F Care Systems USA LLC
510(k) number
K210077
Product code
ONQ  
Decision
Substantially Equivalent (SESE)
Decision date
2021-12-17
Date received
2021-01-12
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
No

Applicant Contact#

Contact
Patrick Danciu
Address
11098 Biscayne Blvd. Suite 301 Miami FL US 33161 33161

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
K130283EVRF SYSTEMF Care Systems NV2013-03-07
K112334VEIN-GOGH INSTRUMENTRefine USA, LLC2012-05-08
K083352VEINWAVE, TC3000Newlands Clinical Trials, Ltd.2009-06-12

Legacy Summary#

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FDA Review#

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