PHACOFRAGMENTATION SYSTEM MEGATRON

PHACOFRAGMENTATION SYSTEM MEGATRON is an FDA 510(k)-cleared medical device (K002031) manufactured by Asclepion-Meditec AG. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 26, 2000. Regulation: 8.