The following data is part of a premarket notification filed by Bausch & Lomb with the FDA for Stellaris Pc Vision Enhancement System.
| Device ID | K133486 |
| 510k Number | K133486 |
| Device Name: | STELLARIS PC VISION ENHANCEMENT SYSTEM |
| Classification | Unit, Phacofragmentation |
| Applicant | BAUSCH & LOMB 3365 TREE CT. INDUSTRIAL BLVD St. Louis, MO 63122 |
| Contact | Timothy W Capehart |
| Correspondent | Timothy W Capehart 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 | 2013-11-13 |
| Decision Date | 2014-03-12 |
| Summary: | summary |