K233398 is an FDA 510(k) clearance for the Faros Surgical System. This device is classified as a Unit, Phacofragmentation (Class II - Special Controls, product code HQC).
Submitted by Oertli Instrumente AG (Berneck, CH). The FDA issued a Cleared decision on June 27, 2024, 268 days after receiving the submission on October 3, 2023.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4670.
| 510(k) Number | K233398 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 03, 2023 |
| Decision Date | June 27, 2024 |
| Days to Decision | 268 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 |