Contamac, Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
18
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K212631Optimum Infinite (tisilfocon A) Daily Wear Contact LensesMarch 17, 2022
K182304Hyper GP (tisilfocon A) Daily Wear Contact LensNovember 23, 2018
K181566NutrifillOctober 22, 2018
K180616OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear CoApril 25, 2018
K171575ENFLU 18 (enflufocon A) Daily Wear Contact LensOctober 24, 2017
K171077HEXA100 (hexafocon A) Daily Wear Contact LensesAugust 1, 2017
K161100Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact LensesAugust 10, 2016
K160859OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)July 13, 2016
K150590CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49 (hioxifilcon BJuly 10, 2015
K081178OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSESOctober 9, 2008
K070628OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS.May 1, 2007
K062548MODIFICATION TO OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSESNovember 1, 2006
K033594OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSESMarch 19, 2004
K023989CONTAFLEX 55 (METHAFILCON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT)February 26, 2003
K023987CONTAFLEX 38 (POLYMACON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT)February 26, 2003
K024045CONTAFLEX GM3 49% (ACOFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-February 14, 2003
K023349CONTAFLEX GM3 58% (ACOFILCON A) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-December 24, 2002
K021977HYBRID FS & HYBRID FS TORIC (HYCOFOCON A) RGP CONTACT LENS FOR DAILY WEARSeptember 12, 2002