← Back to catalogue

Starlight Imaging Catheter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K243016

by Spectrawave, Inc.

Identifiers

510(k) Number
K243016 FDA 510(k)
FDA Product Code
NQQ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1560 FDA 510(k)
Regulation Number
892.1560 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Starlight Imaging Catheter is an intravascular imaging device designed for Optical Coherence Tomography (OCT) and Near-Infrared Spectroscopy (NIRS). It provides high-resolution cross-sectional imaging of coronary arteries, enabling detailed visualization of vessel structure, plaque composition, and elastic elastic layer (EEL) for precise characterization of atherosclerotic lesions. The device combines depth, resolution, and spectroscopic analysis to support comprehensive assessment during interventional procedures.

This catheter is intended for single-use in radiology settings and is supplied sterile. It is classified as a Class II medical device under FDA regulations (21 CFR 892.1560) and holds a Special 510(k) clearance (K243016) with a decision date of March 20, 2025. The device is compatible with intravascular imaging systems and is regulated under the product code NQQ. No MRI safety information is specified in the available data.

Frequently asked questions

What types of imaging does the Starlight Imaging Catheter provide, and how does this benefit coronary artery assessment?

The Starlight Imaging Catheter combines Optical Coherence Tomography (OCT) and Near-Infrared Spectroscopy (NIRS) to deliver high-resolution cross-sectional imaging of coronary arteries. OCT offers detailed visualization of vessel structure, including the elastic elastic layer (EEL), while NIRS provides spectroscopic analysis of plaque composition. Together, these modalities enable precise characterization of atherosclerotic lesions, supporting better decision-making during interventional procedures.

Is the Starlight Imaging Catheter intended for reuse, or is it designed for single-use only?

The Starlight Imaging Catheter is explicitly designed for single-use in radiology settings. This design ensures patient safety and sterility, as it is supplied sterile and not intended for repeated use.

What regulatory pathway was followed for the Starlight Imaging Catheter, and what does this mean for its use?

The Starlight Imaging Catheter underwent a Special 510(k) review (K243016) and was determined to be substantially equivalent to a predicate device. It is classified as a Class II medical device under FDA regulations (21 CFR 892.1560) and is regulated under product code NQQ. This pathway ensures it meets FDA standards for safety and effectiveness before clinical use.

Can the Starlight Imaging Catheter be used with any intravascular imaging system, or are there specific compatibility requirements?

The Starlight Imaging Catheter is compatible with intravascular imaging systems, though exact system requirements should be confirmed with the manufacturer. Its design integrates OCT and NIRS capabilities, so it is intended to work seamlessly with systems that support these imaging modalities for coronary artery assessment.

Are there any special storage instructions for the Starlight Imaging Catheter, given it is supplied sterile?

While the provided data does not specify exact storage instructions, the catheter is supplied sterile and designed for single-use. Standard sterile medical device storage practices—such as protecting from contamination, extreme temperatures, and physical damage—should be followed until use. Always refer to the manufacturer’s packaging or instructions for precise handling guidelines.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Product - SpectraWAVE, Inc., SpectraWAVE, Inc. | Medical Imaging | United States, AccessGUDID - DEVICE: Starlight Imaging Catheter (00860008045508)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Spectrawave, Inc.

Sources (1)

  • FDA 510(k) K243016 24 fields · synced Sep 20, 2026