Clearance Summary
InMode Evolve System with the Tone Applicator received FDA 510(k) clearance under submission number K201285, sponsored by InMode , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2021-03-05.
- Submission: K201285
- Applicant / Sponsor: InMode , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 2021-03-05
Classification & Regulation
This clearance is catalogued under FDA product code IPF and 21 CFR 890.5850, within the Physical Medicine review panel as a Class II device.