Cleared Traditional

VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System (K242893) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K242893 · Luma Vision Limited · Cardiovascular device
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Mar 2025
Decision
182d
Days
Class 2
Risk

K242893 is an FDA 510(k) clearance for the VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System. Classified as Catheter, Ultrasound, Intravascular (product code OBJ), Class II - Special Controls.

Submitted by Luma Vision Limited (Dublin, IE). The FDA issued a Cleared decision on March 24, 2025 after a review of 182 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Luma Vision Limited devices

Submission Details

510(k) Number K242893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 125d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OBJ Catheter, Ultrasound, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
Definition For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - OBJ Catheter, Ultrasound, Intravascular

All 42
Devices cleared under the same product code (OBJ) and FDA review panel - the closest regulatory comparables to K242893.
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NUVISION™ Ultrasound Catheter
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SOUNDSTAR™ CRYSTAL Ultrasound Catheter
K240050 · Biosense Webster, Inc. · Jun 2024
Provisio™ SLT IVUS™ System
K233948 · Provisio Medical, Inc. · Apr 2024