Clearance Summary
Monotime and Optime R received FDA 510(k) clearance under submission number K233265, sponsored by Peters Surgical. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2024-10-11.
- Submission: K233265
- Applicant / Sponsor: Peters Surgical
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4493
- Decision date: 2024-10-11
Classification & Regulation
This clearance is catalogued under FDA product code GAM and 21 CFR 878.4493, within the General, Plastic Surgery review panel as a Class II device.