VISUMAX LASER KERATOME

VISUMAX LASER KERATOME is an FDA 510(k)-cleared medical device (K100253) manufactured by Carl Zeiss 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 July 7, 2010. Regulation: 8.