K213467 is an FDA 510(k) clearance for the EVA NEXUS Ophthalmic Surgical System. This device is classified as a Unit, Phacofragmentation (Class II - Special Controls, product code HQC).
Submitted by D.O.R.C. Dutch Ophthalmic Research Center (International) (Zuidland, NL). The FDA issued a Cleared decision on June 14, 2022, 229 days after receiving the submission on October 28, 2021.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4670.
| 510(k) Number | K213467 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 2021 |
| Decision Date | June 14, 2022 |
| Days to Decision | 229 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 |