QVJ
- Product code
- QVJ
- Device name
- Low Power Electrosurgical Devices For Skin Lesion Destruction
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.4400
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 4
FDA classification 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
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K233760 | 2024-02-20 | Shenzhen Leaflife Technology Co., Ltd. | Mjolnir Pro. (Multielectrode plasma) | |
| K220493 | 2023-10-27 | Gcs Co. Limited | Plaxpot Multi Plasma |
Official FDA classification page: QVJ
Classification and pathway per current FDA publications. Data from openFDA (CC0).