ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626

ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626 is an FDA 510(k)-cleared medical device (K012435) manufactured by Bausch & Lomb, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on October 1, 2001. Regulation: 8.