FDA 510(k) Applications Submitted by CONTAMAC Ltd.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K021977 |
06/17/2002 |
HYBRID FS & HYBRID FS TORIC (HYCOFOCON A) RGP CONTACT LENS FOR DAILY WEAR |
CONTAMAC LTD. |
| K070628 |
03/07/2007 |
OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS. |
CONTAMAC LTD. |
| K081178 |
04/25/2008 |
OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES |
CONTAMAC LTD. |
| K062548 |
08/30/2006 |
MODIFICATION TO OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES |
CONTAMAC LTD. |
| K023349 |
10/07/2002 |
CONTAFLEX GM3 58% (ACOFILCON A) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) |
CONTAMAC LTD. |
| K033594 |
11/13/2003 |
OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES |
CONTAMAC LTD. |
| K023987 |
12/02/2002 |
CONTAFLEX 38 (POLYMACON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) |
CONTAMAC LTD. |
| K023989 |
12/02/2002 |
CONTAFLEX 55 (METHAFILCON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) |
CONTAMAC LTD. |
| K024045 |
12/06/2002 |
CONTAFLEX GM3 49% (ACOFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) |
CONTAMAC LTD. |
| K180616 |
03/08/2018 |
OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens |
Contamac Ltd. |
| K160859 |
03/29/2016 |
OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) |
CONTAMAC LTD. |
| K171077 |
04/11/2017 |
HEXA100 (hexafocon A) Daily Wear Contact Lenses |
CONTAMAC Ltd. |
| K161100 |
04/19/2016 |
Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses |
CONTAMAC LTD. |
| K171575 |
05/30/2017 |
ENFLU 18 (enflufocon A) Daily Wear Contact Lens |
CONTAMAC Ltd. |
| K181566 |
06/14/2018 |
Nutrifill |
Contamac Ltd. |
| K212631 |
08/19/2021 |
Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses |
Contamac Ltd. |
| K182304 |
08/24/2018 |
Hyper GP (tisilfocon A) Daily Wear Contact Lens |
CONTAMAC LTD. |
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