Clearance Summary
VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System received FDA 510(k) clearance under submission number K242893, sponsored by Luma Vision Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2025-03-24.
- Submission: K242893
- Applicant / Sponsor: Luma Vision Limited
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1200
- Decision date: 2025-03-24
Classification & Regulation
This clearance is catalogued under FDA product code OBJ and 21 CFR 870.1200, within the Cardiovascular review panel as a Class II device.