KCP (KELMAN COMPACT PHACO-EMULSIFIER) PEA

KCP (KELMAN COMPACT PHACO-EMULSIFIER) PEA is an FDA 510(k)-cleared medical device (K850149) manufactured by CooperVision, 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 April 14, 1985. Regulation: 8.