The following data is part of a premarket notification filed by Visionsense Ltd. with the FDA for Vs3-iridium System (vs3-ir).
| Device ID | K223020 |
| 510k Number | K223020 |
| Device Name: | VS3-Iridium System (VS3-IR) |
| Classification | Confocal Optical Imaging |
| Applicant | Visionsense Ltd. 20 Hamagshimim St. Petach Tikva, Hamerkaz, IL 4934829 |
| Contact | Guy Wroclawski |
| Correspondent | Guy Wroclawski Visionsense Ltd. 20 Hamagshimim St. Petach Tikva, Hamerkaz, IL 4934829 |
| Product Code | OWN |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-09-29 |
| Decision Date | 2022-10-28 |