Clearance Summary
NuFACE FIX Skin Toning Device received FDA 510(k) clearance under submission number K182424, 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 2018-12-18.
- Submission: K182424
- 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: 2018-12-18
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.