KPE PLUS-PAK SURGICAL SYSTEM

KPE PLUS-PAK SURGICAL SYSTEM is an FDA 510(k)-cleared medical device (K833962) manufactured by Ipax, 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 March 11, 1984. Regulation: 8.