FDA 510(k) Applications for Medical Device Product Code "ONQ"
(Electrosurgical Coagulation For Aesthetic)

FDA 510(k) Number Applicant Device Name Decision Date
K130283 F CARE SYSTEMS NV EVRF SYSTEM 03/07/2013
K210077 F Care Systems USA LLC MED RF 4000 12/17/2021
K083352 NEWLANDS CLINICAL TRIALS LTD VEINWAVE, TC3000 06/12/2009
K112334 REFINE USA, LLC VEIN-GOGH INSTRUMENT 05/08/2012


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