ONQ · Electrosurgical Coagulation For Aesthetic
General, Plastic Surgery · 21 CFR 878.4400 · Class 2
Overview
| Product Code | ONQ |
|---|---|
| Device Name | Electrosurgical Coagulation For Aesthetic |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| 3rd-Party Reviewable | Yes |
Identification
An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.
Classification Rationale
Class II.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K210077 | MED RF 4000 | F Care Systems USA, LLC | Dec 17, 2021 | SESE |
| K130283 | EVRF SYSTEM | F Care Systems NV | Mar 7, 2013 | SESE |
| K112334 | VEIN-GOGH INSTRUMENT | Refine USA, LLC | May 8, 2012 | SESE |
| K083352 | VEINWAVE, TC3000 | Newlands Clinical Trials, Ltd. | Jun 12, 2009 | SESE |
Top Applicants
- F Care Systems NV — 1 clearance
- F Care Systems USA, LLC — 1 clearance
- Newlands Clinical Trials, Ltd. — 1 clearance
- Refine USA, LLC — 1 clearance
