VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System— 510(k) K242893

Name: FDA 510(k) clearance K242893
Creator: U.S. Food and Drug Administration
Published: 2025-03-24

Substantially Equivalent

Luma Vision Limited

FDA 510(k) clearance K242893 for VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System, Substantially Equivalent on 2025-03-24. Applicant: Luma Vision Limited. Device class: 2.

Clearance details

Applicant: Luma Vision Limited
Product code: Code OBJ
Device class: Class 2
Regulation: 21 CFR 870.1200
Advisory panel: Cardiovascular
Date received: 2024-09-23
Decision date: 2025-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dublin, IE

Download summary PDF View on FDA.gov ↗

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K261696 — ACUNAV Luxera 4D ICE Catheter2026-09-10
K261849 — VERAFEYE Imaging Catheter (VF-VIC-002)2026-07-24
K252945 — Novasight Hybrid System2026-04-17
K260816 — OptiCross Coronary Imaging Catheter (H749518110) +7 more2026-04-08
K253399 — Visions® PV .014P RX Digital IVUS Catheter; Visions® PV .018 Digital IVUS Catheter2025-10-28

More clearances from Luma Vision Limited

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K260885 — VERAFEYE Imaging and Guidance System (VF-VIS-002)2026-06-15

Adverse events under product code OBJ

product code OBJ

Death: 38
Injury: 634
Malfunction: 3,453
Total: 4,125

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.