ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS

ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS is an FDA 510(k)-cleared medical device (K001144) manufactured by Lasersight Technologies, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on May 4, 2000. Regulation: 8.