HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM

HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM is an FDA 510(k)-cleared medical device (K052891) manufactured by Hawken Industries. This device is classified under the Ophthalmic specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 22, 2006. Regulation: 8.