Clearance Summary
MTONE EVO (MTONE EVO) received FDA 510(k) clearance under submission number K240604, sponsored by M&T S.R.L.. 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 2024-09-20.
- Submission: K240604
- Applicant / Sponsor: M&T S.R.L.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2024-09-20
Classification & Regulation
This clearance is catalogued under FDA product code GEX and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.