K232084 is an FDA 510(k) clearance for the Stellaris Elite vision enhancement system. This device is classified as a Unit, Phacofragmentation (Class II - Special Controls, product code HQC).
Submitted by Bausch and Lomb (St. Louis, US). The FDA issued a Cleared decision on February 26, 2024, 228 days after receiving the submission on July 13, 2023.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4670.
| 510(k) Number | K232084 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 2023 |
| Decision Date | February 26, 2024 |
| Days to Decision | 228 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQC - Unit, Phacofragmentation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4670 |