MENICON Z BIFOCAL DESIGN LENS/MENICON Z TRIFOCAL DESIGN LENS

MENICON Z BIFOCAL DESIGN LENS/MENICON Z TRIFOCAL DESIGN LENS is an FDA 510(k)-cleared medical device (K970019) manufactured by Menicon U.S.A., 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 24, 1997. Regulation: 8.