Cleared Special

Starlight Imaging Catheter

K243016 · Spectrawave, Inc. · Cardiovascular

Mar 2025

Decision

174d

Days

Class 2

Risk

About This 510(k) Submission

K243016 is an FDA 510(k) clearance for the Starlight Imaging Catheter, a System, Imaging, Optical Coherence Tomography (oct) (Class II — Special Controls, product code NQQ), submitted by Spectrawave, Inc. (Bedford, US). The FDA issued a Cleared decision on March 20, 2025, 174 days after receiving the submission on September 27, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number	K243016 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 27, 2024
Decision Date	March 20, 2025
Days to Decision	174 days
Submission Type	Special
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.