OPTI-ONE MULTI-PURPOSE SOLUTION

OPTI-ONE MULTI-PURPOSE SOLUTION is an FDA 510(k)-cleared medical device (K983973) manufactured by Alcon Laboratories. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 17, 1998. Regulation: 8.