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FDA 510(k)

VERAFEYE Imaging and Guidance System (VF-VIS-002)

K-Number: K260885 · 2026-06-15

ApplicantLuma Vision Limited
Decision Date2026-06-15
Product Code
DecisionSubstantially Equivalent

Device Summary

VERAFEYE Imaging and Guidance System (VF-VIS-002) is the device name listed in this FDA 510(k) record. The listed applicant is Luma Vision Limited. It received FDA 510(k) clearance on 2026-06-15 under 510(k) number K260885. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERAFEYE Imaging and Guidance System (VF-VIS-002)?

VERAFEYE Imaging and Guidance System (VF-VIS-002) is a medical device that received FDA 510(k) clearance on 2026-06-15. The listed applicant is Luma Vision Limited. The 510(k) number is K260885.

When did VERAFEYE Imaging and Guidance System (VF-VIS-002) receive FDA 510(k) clearance?

VERAFEYE Imaging and Guidance System (VF-VIS-002) received FDA 510(k) clearance on 2026-06-15, under 510(k) number K260885.

Who is the listed applicant for VERAFEYE Imaging and Guidance System (VF-VIS-002)?

The FDA 510(k) record lists Luma Vision Limited as the applicant. This does not by itself establish the device manufacturer.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07271238Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation ProceduresRECRUITINGNCT07686328A Multicenter Feasibility Study With the VERAFEYE Imaging and Guidance System as Anatomical Navigation SystemNOT_YET_RECRUITINGNCT07210151Anatomical Navigation for Guided Electrophysiology in AFL and AFibRECRUITINGNCT06895187Catheter Ablation Using a Novel Navigation and Imaging SystemNOT_YET_RECRUITINGNCT06293430Registry on Luma Vision's VERAFEYE System (ENLIgHT)NOT_YET_RECRUITING

Other records listing Luma Vision Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261849VERAFEYE Imaging Catheter (VF-VIC-002)K242893VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System

Official Source

View on FDA Database →

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

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