The following data is part of a premarket notification filed by F Care Systems Usa Llc with the FDA for Med Rf 4000.
| Device ID | K210077 |
| 510k Number | K210077 |
| Device Name: | MED RF 4000 |
| Classification | Electrosurgical Coagulation For Aesthetic |
| Applicant | F Care Systems USA LLC 11098 Biscayne BLVD Suite 301 Miami, FL 33161 |
| Contact | Patrick Danciu |
| Correspondent | Patrick Danciu F Care Systems USA LLC 11098 Biscayne BLVD Suite 301 Miami, FL 33161 |
| Product Code | ONQ |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-12 |
| Decision Date | 2021-12-17 |