AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECE

AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECE is an FDA 510(k)-cleared medical device (K941603) manufactured by Allergan Medical Optics. This device is classified under the Ophthalmic specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 5, 1994. Regulation: 8.