The following data is part of a premarket notification filed by Visionsense Ltd with the FDA for Vs3-ir System.
| Device ID | K152204 |
| 510k Number | K152204 |
| Device Name: | VS3-IR System |
| Classification | Confocal Optical Imaging |
| Applicant | VISIONSENSE LTD 20 HAMAGSHIMIM ST Petach Tikva, Hamerkaz, IL 49348 |
| Contact | Alex Chanin |
| Correspondent | Raymond Kelly LICENSALE INC 57 LAZY BROOK RD Monroe, CT 06468 |
| Product Code | OWN |
| Subsequent Product Code | GCJ |
| Subsequent Product Code | GWG |
| Subsequent Product Code | HRX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2015-08-06 |
| Decision Date | 2015-10-28 |
| Summary: | summary |