Clearance Summary
InMode System with the Morpheus8 (Fractora) Applicators received FDA 510(k) clearance under submission number K192695, sponsored by Inmode MD , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2019-12-27.
- Submission: K192695
- Applicant / Sponsor: Inmode MD , Ltd.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2019-12-27
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.