METRO FOCAL ASPHERIC (POLYMACON)

METRO FOCAL ASPHERIC (POLYMACON) is an FDA 510(k)-cleared medical device (K961606) manufactured by Metro Optics of Austin, 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 November 19, 1996. Regulation: 8.