Cleared Traditional

K242098 - Cornaris Intravascular Imaging System (P80-E) (FDA 510(k) Clearance)

Also includes:
Cornaris Intravascular Imaging System (Mobile-E) LumenCross Imaging Catheter (F2)

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

K242098 · Shenzhen Vivolight Medical Device & Technology Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2025
Decision
267d
Days
Class 2
Risk

K242098 is an FDA 510(k) clearance for the Cornaris Intravascular Imaging System (P80-E). Classified as System, Imaging, Optical Coherence Tomography (oct) (product code NQQ), Class II - Special Controls.

Submitted by Shenzhen Vivolight Medical Device & Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on April 11, 2025 after a review of 267 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 892.1560 - 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 Shenzhen Vivolight Medical Device & Technology Co., Ltd. devices

Submission Details

510(k) Number K242098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2024
Decision Date April 11, 2025
Days to Decision 267 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
142d slower than avg
Panel avg: 125d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NQQ System, Imaging, Optical Coherence Tomography (oct)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
Definition This Device Uses Back-reflected Light To Create Two-dimensional Images Versus Back-reflected Sound Waves As Are Used In Ultrasound Imaging.
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 - NQQ System, Imaging, Optical Coherence Tomography (oct)

All 45
Devices cleared under the same product code (NQQ) and FDA review panel - the closest regulatory comparables to K242098.
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