K190875 is an FDA 510(k) clearance for the EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector). 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 September 25, 2019, 174 days after receiving the submission on April 4, 2019.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4670.
| 510(k) Number | K190875 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 2019 |
| Decision Date | September 25, 2019 |
| Days to Decision | 174 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 |