Contamac, Ltd.
Contamac, Ltd. has 0 FDA recalls, 2 inspections, 18 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Apr 3, 2025 · VAI
- Latest 510(k)
- Mar 17, 2022
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Oct 23, 2026 | Not stated | Current |
| 510(k) clearances | 18 | Oct 4, 2026 | Not stated | Current |
| Inspections | 2 | Oct 25, 2026 | Not stated | Current |
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 3, 2025 | Saffron Walden, United Kingdom | Devices | Voluntary Action Indicated (VAI) | 3001190611 |
| Mar 2, 2010 | Saffron Walden, United Kingdom | Devices | No Action Indicated (NAI) | 3005173140 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K212631 | Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses | Mar 17, 2022 |
| K182304 | Hyper GP (tisilfocon A) Daily Wear Contact Lens | Nov 23, 2018 |
| K181566 | Nutrifill | Oct 22, 2018 |
| K180616 | OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear… | Apr 25, 2018 |
| K171575 | ENFLU 18 (enflufocon A) Daily Wear Contact Lens | Oct 24, 2017 |
| K171077 | HEXA100 (hexafocon A) Daily Wear Contact Lenses | Aug 1, 2017 |
| K161100 | Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses | Aug 10, 2016 |
| K160859 | OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) | Jul 13, 2016 |
| K150590 | CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49 (hioxifilcon… | Jul 10, 2015 |
| K081178 | OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES | Oct 9, 2008 |
| K070628 | OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS. | May 1, 2007 |
| K062548 | MODIFICATION TO OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES | Nov 1, 2006 |
| K033594 | OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES | Mar 19, 2004 |
| K023987 | CONTAFLEX 38 (POLYMACON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) | Feb 26, 2003 |
| K023989 | CONTAFLEX 55 (METHAFILCON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) | Feb 26, 2003 |
| K024045 | CONTAFLEX GM3 49% (ACOFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED… | Feb 14, 2003 |
| K023349 | CONTAFLEX GM3 58% (ACOFILCON A) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED… | Dec 24, 2002 |
| K021977 | HYBRID FS & HYBRID FS TORIC (HYCOFOCON A) RGP CONTACT LENS FOR DAILY WEAR | Sep 12, 2002 |