VISITEC OPHTHALMIC ASPIRATION UNIT MODEL 100

VISITEC OPHTHALMIC ASPIRATION UNIT MODEL 100 is an FDA 510(k)-cleared medical device (K853961) manufactured by Visitec Co.. 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 12, 1985. Regulation: 8.