The following data is part of a premarket notification filed by Bausch + Lomb with the FDA for Stellaris Elite Vision Enhancement System.
| Device ID | K162342 |
| 510k Number | K162342 |
| Device Name: | Stellaris Elite Vision Enhancement System |
| Classification | Unit, Phacofragmentation |
| Applicant | Bausch + Lomb 3365 Tree Ct. Industrial Blvd. St. Louis, MO 63122 |
| Contact | Ken Nehmer |
| Correspondent | Ken Nehmer Bausch + Lomb 3365 Tree Ct. Industrial Blvd. St. Louis, MO 63122 |
| Product Code | HQC |
| Subsequent Product Code | HQE |
| Subsequent Product Code | HQF |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-22 |
| Decision Date | 2017-03-24 |
| Summary: | summary |