Clearance Summary
NuFACE® FIX+ received FDA 510(k) clearance under submission number K240564, sponsored by Carol Cole Company Dba Nuface®. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2024-06-27.
- Submission: K240564
- Applicant / Sponsor: Carol Cole Company Dba Nuface®
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2024-06-27
Classification & Regulation
This clearance is catalogued under FDA product code NFO and 21 CFR 882.5890, within the Neurology review panel as a Class II device.