K243016 is an FDA 510(k) clearance for the Starlight Imaging Catheter. This device is classified as 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 FDA review panel. Regulated under 21 CFR 892.1560. This Device Uses Back-reflected Light To Create Two-dimensional Images Versus Back-reflected Sound Waves As Are Used In Ultrasound Imaging..
| 510(k) Number | K243016 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| 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. |