JETT PLASMA Medical II
FDA 510(k) K213247 · Compex, Spol, S.R.O.
510(k) numberK213247
Submission
- Device name
- JETT PLASMA Medical II
- Applicant
- Compex, Spol, S.R.O.
Brno, CZ - Received
- September 30, 2021
- Decision date
- March 14, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- QVJ – Low Power Electrosurgical Devices For Skin Lesion Destruction
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
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
Other 510(k)s with product code QVJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K233760 | Mjolnir Pro. (Multielectrode plasma)QVJ · Traditional | Shenzhen Leaflife Technology Co., Ltd. | 02/20/2024SE |
| K220493 | Plaxpot Multi PlasmaQVJ · Traditional | Gcs Co. Limited | 10/27/2023SE |
| K223440 | Plasma Pen (Plasma MD); Plasma Pen (Plasma +)QVJ · Traditional | Plasma Concepts | 03/02/2023SE |
More from Plasma Concepts
| 510(k) | Device | Decision |
|---|---|---|
| K240311 | JETT Medical IIGEI · Traditional | 01/22/2025SE |
Questions and answers
When was JETT PLASMA Medical II cleared by the FDA?
JETT PLASMA Medical II (K213247) received a 510(k) decision of Substantially Equivalent on March 14, 2023, 530 days after the submission was received.
What is the product code of K213247?
The FDA product code is QVJ – Low Power Electrosurgical Devices For Skin Lesion Destruction, a Class II (moderate risk) device regulated under 21 CFR 878.4400.