PHAKOSYSTEMS MODEL 1000/OMNI PACKS IRRIGATION/ASPIRATION

PHAKOSYSTEMS MODEL 1000/OMNI PACKS IRRIGATION/ASPIRATION is an FDA 510(k)-cleared medical device (K830871) manufactured by Phakosystems, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on June 1, 1983. Regulation: 8.