Medical Device Manufacturer · US , Littleton , CO

Contamac, Ltd. - FDA 510(k) Cleared Devices

18 submissions · 18 cleared · Since 2002
18
Total
18
Cleared
0
Denied

FDA 510(k) cleared devices by Contamac, Ltd. Ophthalmic

18 devices
1-18 of 18
Cleared Mar 17, 2022
Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses
K212631 · HQD
Ophthalmic · 210d
Cleared Nov 23, 2018
Hyper GP (tisilfocon A) Daily Wear Contact Lens
K182304 · HQD
Ophthalmic · 91d
Cleared Oct 22, 2018
Nutrifill
K181566 · MRC
Ophthalmic · 130d
Cleared Apr 25, 2018
OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100...
K180616 · HQD
Ophthalmic · 48d
Cleared Oct 24, 2017
ENFLU 18 (enflufocon A) Daily Wear Contact Lens
K171575 · HQD
Ophthalmic · 147d
Cleared Aug 01, 2017
HEXA100 (hexafocon A) Daily Wear Contact Lenses
K171077 · HQD
Ophthalmic · 112d
Cleared Aug 10, 2016
Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses
K161100 · HQD
Ophthalmic · 113d
Cleared Jul 13, 2016
OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)
K160859 · MUW
Ophthalmic · 106d
Cleared Jul 10, 2015
CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear,...
K150590 · LPL
Ophthalmic · 123d
Cleared Oct 09, 2008
OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT...
K081178 · HQD
Ophthalmic · 167d
Cleared May 01, 2007
OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS.
K070628 · HQD
Ophthalmic · 55d
Cleared Nov 01, 2006
MODIFICATION TO OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES
K062548 · HQD
Ophthalmic · 63d
Cleared Mar 19, 2004
OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES
K033594 · HQD
Ophthalmic · 127d
Cleared Feb 26, 2003
CONTAFLEX 38 (POLYMACON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR...
K023987 · LPL
Ophthalmic · 86d
Cleared Feb 26, 2003
CONTAFLEX 55 (METHAFILCON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR...
K023989 · LPL
Ophthalmic · 86d
Cleared Feb 14, 2003
CONTAFLEX GM3 49% (ACOFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR...
K024045 · LPL
Ophthalmic · 70d
Cleared Dec 24, 2002
CONTAFLEX GM3 58% (ACOFILCON A) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR...
K023349 · LPL
Ophthalmic · 78d
Cleared Sep 12, 2002
HYBRID FS & HYBRID FS TORIC (HYCOFOCON A) RGP CONTACT LENS FOR DAILY WEAR
K021977 · HQD
Ophthalmic · 87d
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