K153479 is an FDA 510(k) clearance for the NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System. This device is classified as a System, Imaging, Optical Coherence Tomography (oct) (Class II - Special Controls, product code NQQ).
Submitted by Ninepoint Medical, Inc. (Bedford, US). The FDA issued a Cleared decision on February 16, 2016, 76 days after receiving the submission on December 2, 2015.
This device falls under the General & Plastic Surgery 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 | K153479 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Abbreviated 510(k) (SESU) |
| Date Received | December 02, 2015 |
| Decision Date | February 16, 2016 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| 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. |