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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 the device name listed in this FDA 510(k) record. The listed applicant is Luma Vision Limited. It received FDA 510(k) clearance on 2025-03-24 under 510(k) 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. The listed applicant is Luma Vision Limited. The 510(k) number is K242893.

When did VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System receive FDA 510(k) clearance?

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

Who is the listed applicant for VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System?

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

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.

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.

NCT06895187Catheter Ablation Using a Novel Navigation and Imaging SystemNOT_YET_RECRUITINGNCT07271238Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation ProceduresRECRUITINGNCT06293430Registry on Luma Vision's VERAFEYE System (ENLIgHT)NOT_YET_RECRUITINGNCT07210151Anatomical Navigation for Guided Electrophysiology in AFL and AFibRECRUITINGNCT07686328A Multicenter Feasibility Study With the VERAFEYE Imaging and Guidance System as Anatomical Navigation SystemNOT_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)K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)

Related Devices (Code: OBJ)

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)Luma Vision LimitedK252945Novasight Hybrid SystemConavi Medical, Inc.K260816OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090)Boston ScientificK253399Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS CatheterVolcano Corporation (Dba Philips Image Guided Therapy DeviceK250955XC11 ICE System, USAYorlabs, Inc.K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.

Official Source

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