K223440 is an FDA 510(k) clearance for the Plasma Pen (Plasma MD); Plasma Pen (Plasma +). This device is classified as a Low Power Electrosurgical Devices For Skin Lesion Destruction (Class II - Special Controls, product code QVJ).
Submitted by Plasma Concepts (Woburn, US). The FDA issued a Cleared decision on March 2, 2023, 108 days after receiving the submission on November 14, 2022.
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 | K223440 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 2022 |
| Decision Date | March 02, 2023 |
| Days to Decision | 108 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| 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 |