Data / Medical devices / Belgium / Fcare Systems NV
Fcare Systems NV: FDA-registered device maker in Berchem Antwerpen, Belgium, 6 510(k) clearances
Fcare Systems NV is registered with the FDA (registration 3008264458) in Berchem Antwerpen, Belgium. It lists 2 device types. The FDA files 6 510(k) clearances under its listings, the newest dated June 2, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008264458
- Address
- Uitbreidingstraat 42-46, Berchem Antwerpen, Belgium, B-2600
- Owner or operator
- fcare Systems NV (10043355)
- Roles
- Manufacturer
- First device listed
- February 7, 2013
- Registered through
- 2026
- Brand names listed
- 00MedRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, CR45iT, EVRF, F Care RF System, HPR45i, MedRF4000 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical Coagulation For Aesthetic | ONQ | 2 | Manufacturer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 2, 2026 | K253918 | Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) | GEI | Substantially Equivalent | F Care Systems USA, LLC | accessdata.fda.gov |
| November 24, 2025 | K252704 | F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St) | GEI | Substantially Equivalent | F Care Systems USA, LLC | accessdata.fda.gov |
| March 20, 2023 | K220725 | HPR45i | GEI | Substantially Equivalent | F Care Systems USA, LLC | accessdata.fda.gov |
| December 17, 2021 | K210077 | MED RF 4000 | ONQ | Substantially Equivalent | F Care Systems USA, LLC | accessdata.fda.gov |
| March 7, 2013 | K130283 | EVRF SYSTEM | ONQ | Substantially Equivalent | F Care Systems NV | accessdata.fda.gov |
| June 12, 2009 | K083352 | VEINWAVE, TC3000 | ONQ | Substantially Equivalent | Newlands Clinical Trials, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Electrosurgical Coagulation For Aesthetic
Updated June 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.