QVJ · Low Power Electrosurgical Devices For Skin Lesion Destruction
General, Plastic Surgery · 21 CFR 878.4400 · Class 2
Overview
| Product Code | QVJ |
|---|---|
| Device Name | Low Power Electrosurgical Devices For Skin Lesion Destruction |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
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 | Mjolnir Pro. (Multielectrode plasma) | Shenzhen Leaflife Technology Co., Ltd. | Feb 20, 2024 | SESE |
| K220493 | Plaxpot Multi Plasma | Gcs Co. Limited | Oct 27, 2023 | SESE |
| K213247 | JETT PLASMA Medical II | Compex, Spol, S.R.O. | Mar 14, 2023 | SESE |
| K223440 | 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
