QVJ — Low Power Electrosurgical Devices For Skin Lesion Destruction Class II
FDA product code QVJ covers "Low Power Electrosurgical Devices For Skin Lesion Destruction", a Class II medical device regulated under 21 CFR 878.4400. Submissions are reviewed by the General, Plastic Surgery panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QVJ
- Device Class
- Class II
- Regulation Number
- 878.4400
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K233760 | shenzhen leaflife technology co | Mjolnir Pro. (Multielectrode plasma) | February 20, 2024 |
| K220493 | gcs co. limited | Plaxpot Multi Plasma | October 27, 2023 |
| K213247 | compex, spol, s.r.o | JETT PLASMA Medical II | March 14, 2023 |
| K223440 | plasma concepts | Plasma Pen (Plasma MD); Plasma Pen (Plasma +) | March 2, 2023 |