Clearance Summary
Plasma Pen (Plasma MD); Plasma Pen (Plasma +) received FDA 510(k) clearance under submission number K223440, sponsored by Plasma Concepts. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2023-03-02.
- Submission: K223440
- Applicant / Sponsor: Plasma Concepts
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2023-03-02
Classification & Regulation
This clearance is catalogued under FDA product code QVJ and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.