Medical Device Manufacturer · US , Miami , FL

F Care Systems USA, LLC - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2021

Recent clearances: Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St), F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St), HPR45i

4
Total
4
Cleared
0
Denied

FDA 510(k) Regulatory Record - F Care Systems USA, LLC General & Plastic Surgery ✕

4 devices
1-4 of 4
Cleared Jun 02, 2026
Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)
K253918 · GEI
General & Plastic Surgery · 176d
Cleared Nov 24, 2025
F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB,...
K252704 · GEI
General & Plastic Surgery · 89d
Cleared Mar 20, 2023
HPR45i
K220725 · GEI
General & Plastic Surgery · 371d
Cleared Dec 17, 2021
MED RF 4000
K210077 · ONQ
General & Plastic Surgery · 339d
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