Medical Device Manufacturer · US , Littleton , CO

Contamac, Ltd.

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

Contamac, Ltd. — FDA 510(k) Submissions

Contamac, Ltd. has submitted 18 FDA 510(k) premarket notifications since 2002, of which 18 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Lens, Contact (other Material) - Daily, Lenses, Soft Contact, Daily Wear, Lens, Contact (orthokeratology), Products, Contact Lens Care, Rigid Gas Permeable . Use the specialty filter in the sidebar to narrow results.

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