The following data is part of a premarket notification filed by Visionsense Ltd. with the FDA for Vs3-ir-mms System.
| Device ID | K150018 |
| 510k Number | K150018 |
| Device Name: | VS3-IR-MMS System |
| Classification | Confocal Optical Imaging |
| Applicant | Visionsense Ltd. 20 Hamagshimim Street Petach Tikva, Hamerkaz, IL 49348 |
| Contact | Alex Chanin |
| Correspondent | Gerard J Prud'homme HOGAN LOVELLS US LLP 555 THIRTEENTH STREET NW COLUMBIA SQUARE Washington, DC 20004 |
| Product Code | OWN |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2015-01-05 |
| Decision Date | 2015-06-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18130400103540 | K150018 | 000 |
| 10813040013742 | K150018 | 000 |
| 10813040013988 | K150018 | 000 |
| 10884521810143 | K150018 | 000 |
| 10884521810167 | K150018 | 000 |
| 10884521812161 | K150018 | 000 |
| 10884521812185 | K150018 | 000 |
| 10884521834644 | K150018 | 000 |
| 18130400103458 | K150018 | 000 |
| 10813040013483 | K150018 | 000 |