K142877 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 Dutch Ophthalmic Research Center International BV (Zuidland, NL). The FDA issued a Cleared decision on March 13, 2015, 163 days after receiving the submission on October 1, 2014.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4670.
| 510(k) Number | K142877 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 2014 |
| Decision Date | March 13, 2015 |
| Days to Decision | 163 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 |