K191117 is an FDA 510(k) clearance for the NvisionVLE Low-profile Optical Probe. 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 July 19, 2019, 84 days after receiving the submission on April 26, 2019.
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 | K191117 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Abbreviated 510(k) (SESU) |
| Date Received | April 26, 2019 |
| Decision Date | July 19, 2019 |
| Days to Decision | 84 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. |