Menicon Co, Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
17
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K193399Miru 1day UpSide (midafilcon A)June 17, 2020
K191872Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting SolutionMarch 2, 2020
K180819One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact LensMay 16, 2018
K180004Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact LensFebruary 22, 2018
K173136Menicon Progent Protein Remover for Rigid Gas Permeable Contact LensesNovember 16, 2017
K151768Menicon Saline Rinse SolutionAugust 28, 2015
K130805MENICON UNIQUE PH MULTI-PURPOSE SOLUTIONJuly 3, 2013
K122273MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSJanuary 2, 2013
K102895ONE DAY FLAT PACKApril 28, 2011
K103561MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSFebruary 3, 2011
K082855MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSESMarch 9, 2010
K081443MENICON Z RIGID GAS PERMEABLE CONTACT LENSSeptember 23, 2008
K020930MENICON PROGENT REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSESMay 2, 2002
K002140MENICON PROGENT REMOVEROctober 10, 2000
K000233MENICON SF-PMay 19, 2000
K962006MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSOctober 9, 1996
K943784MELAFOCON A/RIGID GAS PERM CONTACT LEN FOR DAILY WEAROctober 20, 1994