K210265 is an FDA 510(k) clearance for the VS3 Iridium Sytem. This device is classified as a Confocal Optical Imaging (Class II - Special Controls, product code OWN).
Submitted by Visionsense, Ltd. (Petach Tikva, Hamerkaz, IL). The FDA issued a Cleared decision on November 22, 2021, 294 days after receiving the submission on February 1, 2021.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1500. Collection Of Light Signals For Visualization Of Cellular Microstructures..
| 510(k) Number | K210265 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 2021 |
| Decision Date | November 22, 2021 |
| Days to Decision | 294 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OWN - Confocal Optical Imaging |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | Collection Of Light Signals For Visualization Of Cellular Microstructures. |