Cleared Traditional

VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System

K242893 · Luma Vision Limited · Cardiovascular

Mar 2025

Decision

182d

Days

Class 2

Risk

About This 510(k) Submission

K242893 is an FDA 510(k) clearance for the VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System, a Catheter, Ultrasound, Intravascular (Class II — Special Controls, product code OBJ), submitted by Luma Vision Limited (Dublin, IE). The FDA issued a Cleared decision on March 24, 2025, 182 days after receiving the submission on September 23, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.

Submission Details

510(k) Number	K242893 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 23, 2024
Decision Date	March 24, 2025
Days to Decision	182 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	OBJ — Catheter, Ultrasound, Intravascular
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1200
Definition	For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology.