MANDELKORN SUTURE LYSIS LENS

MANDELKORN SUTURE LYSIS LENS is an FDA 510(k)-cleared medical device (K933976) manufactured by Ocular Instruments, 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 7, 1994. Regulation: 8.