K232789 is an FDA 510(k) clearance for the VIO System (V-1000). This device is classified as a Multi-photon Imaging (Class II - Special Controls, product code QZN).
Submitted by Enspectra Health, Inc. (Mountain View, US). The FDA issued a Cleared decision on December 22, 2023, 102 days after receiving the submission on September 11, 2023.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4580. To Provide Visible Illumination Of The Surgical Field Or The Patient.
| 510(k) Number | K232789 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 2023 |
| Decision Date | December 22, 2023 |
| Days to Decision | 102 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | QZN - Multi-photon Imaging |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4580 |
| Definition | To Provide Visible Illumination Of The Surgical Field Or The Patient |