510(k) K970019

MENICON Z BIFOCAL DESIGN LENS/MENICON Z TRIFOCAL DESIGN LENS by Menicon U.S.A., Inc. — Product Code LPL

K970019 is an FDA 510(k) premarket notification submitted by Menicon U.S.A., Inc. for the device "MENICON Z BIFOCAL DESIGN LENS/MENICON Z TRIFOCAL DESIGN LENS". The FDA issued a decision of Substantially Equivalent on Mar 25, 1997. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925. Menicon U.S.A., Inc. has 2 other 510(k) clearances on record.