Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4400](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4400) → ONQ — Electrosurgical Coagulation For Aesthetic

# ONQ · Electrosurgical Coagulation For Aesthetic

_General, Plastic Surgery · 21 CFR 878.4400 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONQ

## Overview

- **Product Code:** ONQ
- **Device Name:** Electrosurgical Coagulation For Aesthetic
- **Regulation:** [21 CFR 878.4400](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4400)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)
- **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](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONQ/K210077.md) | MED RF 4000 | F Care Systems USA, LLC | Dec 17, 2021 | SESE |
| [K130283](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONQ/K130283.md) | EVRF SYSTEM | F Care Systems NV | Mar 7, 2013 | SESE |
| [K112334](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONQ/K112334.md) | VEIN-GOGH INSTRUMENT | Refine USA, LLC | May 8, 2012 | SESE |
| [K083352](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONQ/K083352.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONQ](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONQ)

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