The following data is part of a premarket notification filed by Bausch & Lomb with the FDA for Bausch + Lumb, Vis100 Injector System.
| Device ID | K133146 |
| 510k Number | K133146 |
| Device Name: | BAUSCH + LUMB, VIS100 INJECTOR SYSTEM |
| Classification | Folders And Injectors, Intraocular Lens (iol) |
| Applicant | BAUSCH & LOMB 50 TECHNOLOGY DRIVE Irvine, CA 92618 |
| Contact | Shivani K Chitalia |
| Correspondent | Shivani K Chitalia BAUSCH & LOMB 50 TECHNOLOGY DRIVE Irvine, CA 92618 |
| Product Code | MSS |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-17 |
| Decision Date | 2014-01-03 |
| Summary: | summary |