K213247 is an FDA 510(k) clearance for the JETT PLASMA Medical II. This device is classified as a Low Power Electrosurgical Devices For Skin Lesion Destruction (Class II - Special Controls, product code QVJ).
Submitted by Compex, Spol, S.R.O. (Brno, CZ). The FDA issued a Cleared decision on March 14, 2023, 530 days after receiving the submission on September 30, 2021.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4400. 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) Number | K213247 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2021 |
| Decision Date | March 14, 2023 |
| Days to Decision | 530 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | QVJ — Low Power Electrosurgical Devices For Skin Lesion Destruction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4400 |
| 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 |