FDA.reportPublic FDA data

MedRF4000

Primary DI
05425025634507
Brand
MedRF4000
Company
F Care Systems
Model
00MEDRF4000US
Device description
F Care RF System is intended to conduct radio frequency (RF) current for coagulation from the RF electrosurgical generator to target soft tissue in a broad range of surgical procedures.
Published
2026-03-30
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
GEIElectrosurgical, Cutting & Coagulation & Accessories
ONQElectrosurgical Coagulation For Aesthetic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2
ONQElectrosurgical Coagulation For AestheticGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252704000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252704000F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St)F Care Systems USA, LLC2025-11-24GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05425025634507PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05425025634507054250256345075425025634507

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
05425025630080EVRF00EVRFV22026-04-08
05425025630288Viridex RF00ViridexRF2026-04-08
05425025630554ThermaVein+00thermaVeinplus2026-04-08
05425025630141HPR45i05HPR45iV22026-03-30
05425025630530MedRF400000MEDRF40002026-03-30
05425025630608Rafaelo probe05RAFAELOPROBE2026-03-30
05425025630615Sphera probe05SPHERAPROBE2026-03-30

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Primary DI, Brand, Company table
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