510(k) K142877

EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(DORC connector), EVA combined machine with laser SMA connector) by Dutch Ophthalmic Research Center International BV — Product Code HQC

K142877 is an FDA 510(k) premarket notification submitted by Dutch Ophthalmic Research Center International BV for the device "EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(DORC connector), EVA combined machine with laser SMA connector)". The FDA issued a decision of Substantially Equivalent on March 13, 2015. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. Dutch Ophthalmic Research Center International BV has at least 3 other 510(k) clearances on record.