Clearance Summary
Evolve System with the T3 Applicator received FDA 510(k) clearance under submission number K210877, sponsored by InMode , Ltd.. 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 2021-07-19.
- Submission: K210877
- Applicant / Sponsor: InMode , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2021-07-19
Classification & Regulation
This clearance is catalogued under FDA product code PBX and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.