Starlight Imaging Catheter
FDA 510(k) K243016 · Spectrawave, Inc.
510(k) numberK243016
Submission
- Device name
- Starlight Imaging Catheter
- Applicant
- Spectrawave, Inc.
Bedford, MA, US - Received
- September 27, 2024
- Decision date
- March 20, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NQQ – System, Imaging, Optical Coherence Tomography (Oct)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.1560
- Specialty
- Radiology
This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging.
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| K240610 | deepLiveNQQ · Traditional | Damae Medical | 07/09/2024SE |
More from Damae Medical
| 510(k) | Device | Decision |
|---|---|---|
| K253101 | HyperVue Imaging System - IntegratedNQQ · Traditional | 12/15/2025SE |
| K251355 | X1-FFRQHA · Traditional | 10/17/2025SE |
| K251198 | HyperVue SoftwareNQQ · Traditional | 07/16/2025SE |
| K230691 | HyperVue Imaging SystemNQQ · Traditional | 06/07/2023SE |
| K221257 | SpectraWAVE Imaging SystemNQQ · Traditional | 02/28/2023SE |
Questions and answers
When was Starlight Imaging Catheter cleared by the FDA?
Starlight Imaging Catheter (K243016) received a 510(k) decision of Substantially Equivalent on March 20, 2025, 174 days after the submission was received.
What is the product code of K243016?
The FDA product code is NQQ – System, Imaging, Optical Coherence Tomography (Oct), a Class II (moderate risk) device regulated under 21 CFR 892.1560.