Clearance Summary
Smart Photon Micro-current Device, Model: EP-300 received FDA 510(k) clearance under submission number K162652, sponsored by Li-Tek Electronic Technology Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2017-10-25.
- Submission: K162652
- Applicant / Sponsor: Li-Tek Electronic Technology Corporation
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2017-10-25
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.