Clearance Summary
Renuvion/J-Plasma Precise Handpiece received FDA 510(k) clearance under submission number K191484, sponsored by Apyx Medical Corporation(Formerly Bovie Medical Corporation). 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 2019-07-30.
- Submission: K191484
- Applicant / Sponsor: Apyx Medical Corporation(Formerly Bovie Medical Corporation)
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2019-07-30
Classification & Regulation
This clearance is catalogued under FDA product code GEI and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.