AMO DIPLOMAX/OPSYS CONSOLE

AMO DIPLOMAX/OPSYS CONSOLE is an FDA 510(k)-cleared medical device (K971186) manufactured by Allergan, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 12, 1997. Regulation: 8.