Data / Medical devices / Japan / Menicon Co., Ltd., R&D Center
Menicon Co., Ltd., R&D Center: FDA-registered device maker in Kasugai Aichi, Japan, 12 510(k) clearances and 1 PMA approval
Menicon Co., Ltd., R&D Center is registered with the FDA (registration 3003062331) in Kasugai Aichi, Japan. It lists 8 device types. The FDA files 12 510(k) clearances and 1 PMA approval under its listings, the newest dated September 17, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003062331
- Address
- 5-1-10, Takamoridai, Kasugai Aichi, Japan, 487-0032
- Owner or operator
- MENICON CO. LTD. (9001029)
- Roles
- Specification developer
- First device listed
- August 13, 2002
- Registered through
- 2026
- Brand names listed
- LacriPure, MENICON SP VIAL, MENICON Z RIGID GAS PERMEABLE CONTACT LENS, MeniSept, Menicon Progent Protein Remover, Menicon Unique pH Multi-Purpose Solution, Menicon Z DW, Menicon Z Irregular Cornea and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Soft Lens Products | LPN | 2 | Specification developer | accessdata.fda.gov |
| Case, Contact Lens | LRX | 2 | Specification developer | accessdata.fda.gov |
| Lens, Contact (Other Material) - Daily | HQD | 2 | Specification developer | accessdata.fda.gov |
| Lens, Contact (Rigid Gas Permeable), Extended Wear | MWL | 3 | Specification developer | accessdata.fda.gov |
| Lens, Contact, (Disposable) | MVN | 2 | Specification developer | accessdata.fda.gov |
| Lens, Contact, Orthokeratology, Overnight | NUU | 3 | Specification developer | accessdata.fda.gov |
| Lenses, Soft Contact, Daily Wear | LPL | 2 | Specification developer | accessdata.fda.gov |
| Products, Contact Lens Care, Rigid Gas Permeable | MRC | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 17, 2026 | K262495 | Miru 1day UpSide (midafilcon A) | LPL | Substantially Equivalent | Menicon Co, Ltd. | accessdata.fda.gov |
| June 17, 2020 | K193399 | Miru 1day UpSide (midafilcon A) | LPL | Substantially Equivalent | Menicon Co, Ltd. | accessdata.fda.gov |
| March 2, 2020 | K191872 | Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution | LPN | Substantially Equivalent | Menicon Co, Ltd. | accessdata.fda.gov |
| February 22, 2018 | K180004 | Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens | LPL | Substantially Equivalent | Menicon Co, Ltd. | accessdata.fda.gov |
| November 16, 2017 | K173136 | Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses | MRC | Substantially Equivalent | Menicon Co, Ltd. | accessdata.fda.gov |
| August 28, 2015 | K151768 | Menicon Saline Rinse Solution | LPN | Substantially Equivalent | Menicon Co, Ltd. | accessdata.fda.gov |
| July 3, 2013 | K130805 | MENICON UNIQUE PH MULTI-PURPOSE SOLUTION | MRC | Substantially Equivalent | Menicon Co, Ltd. | accessdata.fda.gov |
| April 28, 2011 | K102895 | ONE DAY FLAT PACK | LPL | Substantially Equivalent | Menicon Co, Ltd. | accessdata.fda.gov |
| February 3, 2011 | K103561 | MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS | HQD | Substantially Equivalent | Menicon Co, Ltd. | accessdata.fda.gov |
| September 23, 2008 | K081443 | MENICON Z RIGID GAS PERMEABLE CONTACT LENS | HQD | Substantially Equivalent | Menicon Co, Ltd. | accessdata.fda.gov |
| October 9, 1996 | K962006 | MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS | HQD | Substantially Equivalent | Menicon Co, Ltd. | accessdata.fda.gov |
| April 7, 1995 | K950878 | MENICON SP VIAL | LRX | Substantially Equivalent | Hyman, Phelps & McNamara, P.C. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| July 11, 2000 | P990018 | MENICON Z RIGID GAS PERMEABLE CONTACT LENS | MWL | 10 | June 16, 2023 | accessdata.fda.gov |
Compare with other makers
- All makers of Lens, Contact (Other Material) - Daily
- All makers of Lens, Contact, (Disposable)
- All makers of Lenses, Soft Contact, Daily Wear
- All makers of Accessories, Soft Lens Products
- All makers of Products, Contact Lens Care, Rigid Gas Permeable
- All makers of Lens, Contact, Orthokeratology, Overnight
Updated September 17, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.