The following data is part of a premarket notification filed by Bausch & Lomb with the FDA for Stellaris Vision Enhancement System.
| Device ID | K133242 |
| 510k Number | K133242 |
| Device Name: | STELLARIS VISION ENHANCEMENT SYSTEM |
| Classification | Unit, Phacofragmentation |
| Applicant | BAUSCH & LOMB 3365 TREE COURT INDUSTRIAL BLV St Louis, MO 63122 |
| Contact | Timothy W Capehart |
| Correspondent | Timothy W Capehart BAUSCH & LOMB 3365 TREE COURT INDUSTRIAL BLV St Louis, MO 63122 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-21 |
| Decision Date | 2014-02-14 |
| Summary: | summary |