FDA product code QVJ: Low Power Electrosurgical Devices For Skin Lesion Destruction
QVJ is the FDA product code for low power electrosurgical devices for skin lesion destruction. It is a Class II device, regulated under 21 CFR 878.4400 and reviewed by the General and Plastic Surgery panel. FDA has cleared 4 510(k) submissions under QVJ, 4 in the last five years, from 4 different applicants. The average 510(k) review took 334 days (median 319); 88 days on average over the last three years.
Definition
For the removal and destruction of skin lesions in general dermatological procedures, also referred to as Plasma Pen Devices, which generates electrical arc in the ambient air between an electrical probe tip and the skin and cause intended tissue damage for the removal and destruction of skin lesions
Classification
| Field | Value |
|---|---|
| Device name | Low Power Electrosurgical Devices For Skin Lesion Destruction |
| Device class | Class II |
| Regulation | 21 CFR 878.4400 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for QVJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 3 | 417 |
| 2024 | 1 | 88 |
Compare with all 510(k) review times · Search every QVJ clearance
Top QVJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Shenzhen Leaflife Technology Co., Ltd. | 1 | 2024-02-20 |
| Gcs Co. Limited | 1 | 2023-10-27 |
| Compex, Spol, S.R.O. | 1 | 2023-03-14 |
| Plasma Concepts | 1 | 2023-03-02 |
Most recent QVJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233760 | Shenzhen Leaflife Technology Co., Ltd. | Mjolnir Pro. (Multielectrode plasma) | 2024-02-20 | 88 |
| K220493 | Gcs Co. Limited | Plaxpot Multi Plasma | 2023-10-27 | 612 |
| K213247 | Compex, Spol, S.R.O. | JETT PLASMA Medical II | 2023-03-14 | 530 |
| K223440 | Plasma Concepts | Plasma Pen (Plasma MD); Plasma Pen (Plasma +) | 2023-03-02 | 108 |
Recalls for QVJ devices
openFDA lists no recalls for product code QVJ.
Frequently asked questions
What is FDA product code QVJ?
QVJ is the FDA product code for low power electrosurgical devices for skin lesion destruction. It is a Class II device, regulated under 21 CFR 878.4400 and reviewed by the General and Plastic Surgery panel.
What device class is QVJ?
Class II, regulation 21 CFR 878.4400. Typical premarket route: 510(k).
How long does a 510(k) take for product code QVJ?
Across 4 cleared submissions the average was 334 days from receipt to decision (median 319).
Which companies have the most QVJ clearances?
Shenzhen Leaflife Technology Co., Ltd. (1); Gcs Co. Limited (1); Compex, Spol, S.R.O. (1); Plasma Concepts (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QVJ
- Run a recall and safety report across every QVJ manufacturer
- Watch product code QVJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All General and Plastic Surgery product codes · FDA product code lookup · 510(k) database search · 510(k) review times