510(k) K252704 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St)
| Applicant | F Care Systems USA, LLC, Miami FL, US |
| Decision | Substantially Equivalent, Nov 24, 2025 |
| Received | Aug 27, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252704
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.