Company ยท US
Menicon Co, Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 2026. Name variants (Inc, Corp, punctuation) are merged.
22510(k) clearances (2 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 |
|---|---|---|---|
| Sep 17, 2026 | K262495 | Miru 1day UpSide (midafilcon A) Menicon Co, Ltd., JP | LPL |
| Aug 13, 2026 | K253795 | MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution Menicon Co, Ltd., JP | LPN |
| Jun 17, 2020 | K193399 | Miru 1day UpSide (midafilcon A) Menicon Co, Ltd., JP | LPL |
| Mar 2, 2020 | K191872 | Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution Menicon Co, Ltd., JP | LPN |
| May 16, 2018 | K180819 | One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens Menicon Co, Ltd., JP | LPL |
| Feb 22, 2018 | K180004 | Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens Menicon Co, Ltd., JP | LPL |
| Nov 16, 2017 | K173136 | Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses Menicon Co, Ltd., JP | MRC |
| Aug 28, 2015 | K151768 | Menicon Saline Rinse Solution Menicon Co, Ltd., JP | LPN |
| Jul 3, 2013 | K130805 | MENICON UNIQUE PH MULTI-PURPOSE SOLUTION Menicon Co, Ltd. | MRC |
| Jan 2, 2013 | K122273 | MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENS Menicon Co, Ltd. | MRC |
| Apr 28, 2011 | K102895 | ONE DAY FLAT PACK Menicon Co, Ltd. | LPL |
| Feb 3, 2011 | K103561 | MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS Menicon Co, Ltd. | HQD |
| Mar 9, 2010 | K082855 | MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES Menicon Co, Ltd. | MRC |
| Sep 23, 2008 | K081443 | MENICON Z RIGID GAS PERMEABLE CONTACT LENS Menicon Co, Ltd. | HQD |
| May 2, 2002 | K020930 | MENICON PROGENT REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES Menicon Co, Ltd. | MRC |
| Oct 10, 2000 | K002140 | MENICON PROGENT REMOVER Menicon Co, Ltd. | MRC |
| May 19, 2000 | K000233 | MENICON SF-P Menicon Co, Ltd. | HQD |
| May 19, 2000 | K000133 | MENICON Z Menicon U.S.A., Inc. | HQD |
| Aug 22, 1997 | K972443 | MENICON SF-P AND MENICON Z RIGID GAS PERMEABLE CONTACT LENS Menicon U.S.A., Inc. | HQD |
| Mar 25, 1997 | K970019 | MENICON Z BIFOCAL DESIGN LENS/MENICON Z TRIFOCAL DESIGN LENS Menicon U.S.A., Inc. | LPL |
| Oct 9, 1996 | K962006 | MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS Menicon Co, Ltd. | HQD |
| Oct 20, 1994 | K943784 | MELAFOCON A/RIGID GAS PERM CONTACT LEN FOR DAILY WEAR Menicon Co, Ltd. | HQD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||