Clearance Summary
FLEXI-LUME LED SYSTEM received FDA 510(k) clearance under submission number K140281, sponsored by Epic Medical Concepts & Innovations. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2014-07-24.
- Submission: K140281
- Applicant / Sponsor: Epic Medical Concepts & Innovations
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6070
- Decision date: 2014-07-24
Classification & Regulation
This clearance is catalogued under FDA product code EBZ and 21 CFR 872.6070, within the Dental review panel as a Class II device.