K191650 is an FDA 510(k) clearance for the LEGION System. This device is classified as a Unit, Phacofragmentation (Class II - Special Controls, product code HQC).
Submitted by Alcon Research, LLC (Fort Worth, US). The FDA issued a Cleared decision on November 1, 2019, 134 days after receiving the submission on June 20, 2019.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4670.
| 510(k) Number | K191650 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 20, 2019 |
| Decision Date | November 01, 2019 |
| Days to Decision | 134 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 |