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FDA 510(k)

VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System

K-Number: K242893 · 2025-03-24

ApplicantLuma Vision Limited
Decision Date2025-03-24
Product CodeOBJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System is a medical device manufactured by Luma Vision Limited. It received FDA 510(k) clearance on 2025-03-24 under approval number K242893. The device is classified under product code OBJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System?

VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System is a medical device that received FDA 510(k) clearance on 2025-03-24. It is manufactured by Luma Vision Limited. The 510(k) number is K242893.

When was VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System approved by the FDA?

VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System received FDA 510(k) clearance on 2025-03-24, under approval number K242893.

What company makes VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System?

VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System is manufactured by Luma Vision Limited.

What is the FDA product code for VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System?

The FDA product code for VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System is OBJ.

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Related PubMed Literature

PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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