VERAFEYE Imaging Catheter (VF-VIC-002)— 510(k) K261849
Substantially EquivalentLuma Vision Limited
FDA 510(k) clearance K261849 for VERAFEYE Imaging Catheter (VF-VIC-002), Substantially Equivalent on 2026-07-24. Applicant: Luma Vision Limited. Device class: 2.
Summary
Luma Vision's VERAFEYE Imaging Catheter (VF-VIC-002) is filed under OBJ, intravascular ultrasound catheters. The record gives the model as VF-VIC-002 but no dimensions.
Class II, 21 CFR 870.1200. Cardiovascular is both the classification panel and the review panel. It came in as a Special 510(k).
Luma Vision filed from Dublin, Ireland. Review took 51 calendar days (June 3 to July 24, 2026).
Clearance details
- Applicant
- Luma Vision Limited
- Product code
- Product code OBJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.1200
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Dublin, IE
Recent devices under product code OBJ
view allMore clearances from Luma Vision Limited
view allAdverse events under product code OBJ
product code OBJ- Death
- 38
- Injury
- 634
- Malfunction
- 3,453
- Total
- 4,125
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.