K210077 is an FDA 510(k) clearance for the MED RF 4000. This device is classified as a Electrosurgical Coagulation For Aesthetic (Class II - Special Controls, product code ONQ).
Submitted by F Care Systems USA, LLC (Miami, US). The FDA issued a Cleared decision on December 17, 2021, 339 days after receiving the submission on January 12, 2021.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4400. For The Treatment Of Spider Vein Or Telangiectasia By Thermocoagulation..
| 510(k) Number | K210077 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 12, 2021 |
| Decision Date | December 17, 2021 |
| Days to Decision | 339 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | ONQ - Electrosurgical Coagulation For Aesthetic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4400 |
| Definition | For The Treatment Of Spider Vein Or Telangiectasia By Thermocoagulation. |