ZYOPTIX XP EPI SEPARATOR SYSTEM

ZYOPTIX XP EPI SEPARATOR SYSTEM is an FDA 510(k)-cleared medical device (K062465) manufactured by Bausch & Lomb, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on September 5, 2006. Regulation: 8.