Clearance Summary
2 Face / Face Evolution received FDA 510(k) clearance under submission number K171821, sponsored by Heat IN A Click. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2018-04-26.
- Submission: K171821
- Applicant / Sponsor: Heat IN A Click
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2018-04-26
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.