QVJClass II
Low Power Electrosurgical Devices For Skin Lesion Destruction
21 CFR 878.4400 / General, Plastic Surgery
QVJ is the FDA product code for Low Power Electrosurgical Devices For Skin Lesion Destruction, a class II device type, regulated under 21 CFR 878.4400. FDA's definition for this code reads: "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". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QVJ
- Device name
- Low Power Electrosurgical Devices For Skin Lesion Destruction
- FDA 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
- Regulation
- 21 CFR 878.4400
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 4
- Ingested recalls
- 0
Clearances, product code QVJ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2023 | 3 |
| 2024 | 1 |
Applicants with the most clearances
Product code QVJ| Applicant | Clearances |
|---|---|
| Compex, Spol, s.r.o. | 1 |
| Gcs Co. Limited | 1 |
| Plasma Concepts | 1 |
| Shenzhen Leaflife Technology Co., Ltd. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.