Plaxpot Multi Plasma
FDA 510(k) K220493 · Gcs Co. Limited
510(k) numberK220493
Submission
- Device name
- Plaxpot Multi Plasma
- Applicant
- Gcs Co. Limited
Seongnam, KR - Received
- February 22, 2022
- Decision date
- October 27, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| K213247 | JETT PLASMA Medical IIQVJ · Traditional | Compex, Spol, S.R.O. | 03/14/2023SE |
| K223440 | Plasma Pen (Plasma MD); Plasma Pen (Plasma +)QVJ · Traditional | Plasma Concepts | 03/02/2023SE |
Questions and answers
When was Plaxpot Multi Plasma cleared by the FDA?
Plaxpot Multi Plasma (K220493) received a 510(k) decision of Substantially Equivalent on October 27, 2023, 612 days after the submission was received.
What is the product code of K220493?
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.