AIVUS (7000), ASPIRATION AND IRRIGATION DEVICE

AIVUS (7000), ASPIRATION AND IRRIGATION DEVICE is an FDA 510(k)-cleared medical device (K860891) manufactured by Intra-Optics Labs. C/O Newman Assoc.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 20, 1986. Regulation: 8.