Company ยท US
Contamac, Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2022. Name variants (Inc, Corp, punctuation) are merged.
18510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 17, 2022 | K212631 | Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses Contamac, Ltd., GB | HQD |
| Nov 23, 2018 | K182304 | Hyper GP (tisilfocon A) Daily Wear Contact Lens Contamac, Ltd., GB | HQD |
| Oct 22, 2018 | K181566 | Nutrifill Contamac, Ltd., GB | MRC |
| Apr 25, 2018 | K180616 | OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens Contamac, Ltd., GB | HQD |
| Oct 24, 2017 | K171575 | ENFLU 18 (enflufocon A) Daily Wear Contact Lens Contamac, Ltd., GB | HQD |
| Aug 1, 2017 | K171077 | HEXA100 (hexafocon A) Daily Wear Contact Lenses Contamac, Ltd., GB | HQD |
| Aug 10, 2016 | K161100 | Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses Contamac, Ltd., GB | HQD |
| Jul 13, 2016 | K160859 | OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) Contamac, Ltd., GB | MUW |
| Jul 10, 2015 | K150590 | CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49 (hioxifilcon B) Spherical Soft Con Contamac, Ltd., GB | LPL |
| Oct 9, 2008 | K081178 | OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES Contamac, Ltd. | HQD |
| May 1, 2007 | K070628 | OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS. Contamac, Ltd. | HQD |
| Nov 1, 2006 | K062548 | MODIFICATION TO OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES Contamac, Ltd. | HQD |
| Mar 19, 2004 | K033594 | OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES Contamac, Ltd. | HQD |
| Feb 26, 2003 | K023989 | CONTAFLEX 55 (METHAFILCON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) Contamac, Ltd. | LPL |
| Feb 26, 2003 | K023987 | CONTAFLEX 38 (POLYMACON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) Contamac, Ltd. | LPL |
| Feb 14, 2003 | K024045 | CONTAFLEX GM3 49% (ACOFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) Contamac, Ltd. | LPL |
| Dec 24, 2002 | K023349 | CONTAFLEX GM3 58% (ACOFILCON A) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) Contamac, Ltd. | LPL |
| Sep 12, 2002 | K021977 | HYBRID FS & HYBRID FS TORIC (HYCOFOCON A) RGP CONTACT LENS FOR DAILY WEAR Contamac, Ltd. | HQD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||