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) → QVJ — Low Power Electrosurgical Devices For Skin Lesion Destruction

# QVJ · Low Power Electrosurgical Devices For Skin Lesion Destruction

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

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

## Overview

- **Product Code:** QVJ
- **Device Name:** Low Power Electrosurgical Devices For Skin Lesion Destruction
- **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)

## 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 |
| --- | --- | --- | --- | --- |
| [K233760](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/QVJ/K233760.md) | Mjolnir Pro. (Multi–electrode plasma) | Shenzhen Leaflife Technology Co., Ltd. | Feb 20, 2024 | SESE |
| [K220493](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/QVJ/K220493.md) | Plaxpot Multi Plasma | Gcs Co. Limited | Oct 27, 2023 | SESE |
| [K213247](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/QVJ/K213247.md) | JETT PLASMA Medical II | Compex, Spol, S.R.O. | Mar 14, 2023 | SESE |
| [K223440](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/QVJ/K223440.md) | Plasma Pen (Plasma MD); Plasma Pen (Plasma +) | Plasma Concepts | Mar 2, 2023 | SESE |

## Top Applicants

- Compex, Spol, S.R.O. — 1 clearance
- Gcs Co. Limited — 1 clearance
- Plasma Concepts — 1 clearance
- Shenzhen Leaflife Technology Co., Ltd. — 1 clearance

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

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