EVRF

Primary DI
05425025630080
Brand
EVRF
Company
F Care Systems
Model
00EVRFV2
Device description
Intended for the epilation and for the treatment of lower limb spider vein or telangiectasia by thermocoagulation
Published
2026-04-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ONQElectrosurgical Coagulation For Aesthetic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ONQElectrosurgical Coagulation For AestheticGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130283000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130283000EVRF SYSTEMF Care Systems NV2013-03-07ONQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05425025630080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05425025630080054250256300805425025630080

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous radio-frequency ablation system generatorAn electrically-powered, noninvasive device designed to generate radio-frequency (RF) electrical current used to create heat via a percutaneously (through the skin) introduced electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues (e.g., non-cardiac nerves, tumours, precancerous tissue); it may be intended for coagulation however it is not intended for electrosurgical cutting. The generator connects via a delivery cable to an electrosurgical ablation probe/catheter (not included) to transmit the RF electrical current to the operative site; it might additionally be intended to heat an electrode tip (electrocautery).

Contacts#

Phone, Email table
PhoneEmail
+3234515145info@fcaresystems.com

Regulatory Flags#

DUNS number
370516974
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05425025630288Viridex RF00ViridexRF2026-04-08
05425025630554ThermaVein+00thermaVeinplus2026-04-08
05425025630141HPR45i05HPR45iV22026-03-30
05425025630530MedRF400000MEDRF40002026-03-30
05425025630608Rafaelo probe05RAFAELOPROBE2026-03-30
05425025630615Sphera probe05SPHERAPROBE2026-03-30
05425025634507MedRF400000MEDRF4000US2026-03-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05425025630288Viridex RFF Care SystemsONQ2026-04-08
05425025630554ThermaVein+F Care SystemsONQ2026-04-08
05425025630530MedRF4000F Care SystemsONQ2026-03-30
05425025634507MedRF4000F Care SystemsONQ2026-03-30
08800016903317Secret RF Smartcure Applicator With ElectrodesCLASSYS Inc.ONQ2024-10-30
86573000021011VeinGoghAP MEDESTHETICS, INC.ONQ2016-12-22