Cleared Traditional

Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2)

K242098 · Shenzhen Vivolight Medical Device & Technology Co., Ltd. · Cardiovascular

Apr 2025

Decision

267d

Days

Class 2

Risk

About This 510(k) Submission

K242098 is an FDA 510(k) clearance for the Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2), a System, Imaging, Optical Coherence Tomography (oct) (Class II — Special Controls, product code NQQ), submitted by Shenzhen Vivolight Medical Device & Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on April 11, 2025, 267 days after receiving the submission on July 18, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number	K242098 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	NQQ — System, Imaging, Optical Coherence Tomography (oct)
Device Class	Class II — 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.