FDA.reportPublic FDA data

F CARE SYSTEMS USA

Matched from indexed company URL: F Care Systems

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30088169353009438986F CARE SYSTEMS USA1Y2026-01-01755 NE 164TH TERRACE Miami FL US 33162

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
05425025630080EVRF - Intended for the epilation and for the treatment of lower limb spider vein or telangiectasia by thermocoagulation+3234515145info@fcaresystems.com
05425025630141HPR45i - HPR45i is a monopolar electrosurgical electrode intended to remove tissue and control bleeding using radio frequency electrical current. It is a prescription use device which is intended to be used by a licensed doctors or specialist in the healthcare facility/ hospital.+3234515145info@fcaresystems.com
05425025630288Viridex RF - 00ViridexRF+3234515145info@fcaresystems.com
05425025630530MedRF4000 - The MedRF4000 System is intended for the epilation and for the treatment of lower limb spider vein or telangiectasia by thermocoagulation+3234515145info@fcaresystems.com
05425025630554ThermaVein+ - 00thermaVeinplus+3234515145info@fcaresystems.com
05425025630608Rafaelo probe - 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.+3234515145info@fcaresystems.com
05425025630615Sphera probe - 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.+3234515145info@fcaresystems.com
05425025634507MedRF4000 - 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.+3234515145info@fcaresystems.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1258101188400707K220725HPR45iGEI2023-03-20
1258101852421825K210077MED RF 4000ONQ2021-12-17
1258101558790090K143310MoisturemeterDOBH2015-11-19
1258101725576588K130283EVRF SYSTEMONQ2013-03-07
1258101258373465K083352VEINWAVE, TC3000ONQ2009-06-12
1258101420840351K052844KAVS - CATHETER, MODELS 1107100 & 1107060MJN2006-03-20
1258101347839236

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
ONQ42021-12-17
MJN22006-03-20
GEI12023-03-20
OBH12015-11-19

PMN#

HPR45i

2023-03-20

F Care Systems USA, LLC

GUDID#