510(k) K213247
K213247 is an FDA 510(k) premarket notification submitted by Compex, Spol, S.R.O. for the device "JETT PLASMA Medical II". The FDA issued a decision of Substantially Equivalent on March 14, 2023. The device falls under product code QVJ (Low Power Electrosurgical Devices For Skin Lesion Destruction), a Class II device regulated under 21 CFR 878.4400. Compex, Spol, S.R.O. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 14, 2023
- Date Received
- September 30, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Low Power Electrosurgical Devices For Skin Lesion Destruction
- Device Class
- Class II
- Regulation Number
- 878.4400
- Review Panel
- SU
- Submission Type
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