510(k) K190875

EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector) by D.O.R.C. Dutch Ophthalmic Research Center (International) — Product Code HQC

K190875 is an FDA 510(k) premarket notification submitted by D.O.R.C. Dutch Ophthalmic Research Center (International) 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 September 25, 2019. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. D.O.R.C. Dutch Ophthalmic Research Center (International) has at least 1 other 510(k) clearance on record.