Data / Medical devices / Japan / Menicon Co., Ltd. Techno-station
Menicon Co., Ltd. Techno-station: FDA-registered device maker in Kakamigahara Gifu, Japan, 3 510(k) clearances and 1 PMA approval
Menicon Co., Ltd. Techno-station is registered with the FDA (registration 3014769028) in Kakamigahara Gifu, Japan. It lists 3 device types. The FDA files 3 510(k) clearances and 1 PMA approval under its listings, the newest dated February 3, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014769028
- Address
- 1-15 Technoplaza, Kakamigahara Gifu, Japan, 509-0109
- Owner or operator
- MENICON CO. LTD. (9001029)
- Roles
- Manufacturer
- First device listed
- November 9, 2007
- Registered through
- 2026
- Brand names listed
- MENICON Z RIGID GAS PERMEABLE CONTACT LENS, Menicon Z DW, Menicon Z Irregular Cornea, Menicon Z Large Diameter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lens, Contact (Other Material) - Daily | HQD | 2 | Manufacturer | accessdata.fda.gov |
| Lens, Contact (Rigid Gas Permeable), Extended Wear | MWL | 3 | Manufacturer | accessdata.fda.gov |
| Lens, Contact, Orthokeratology, Overnight | NUU | 3 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| 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 |
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, Orthokeratology, Overnight
- All makers of Lens, Contact (Rigid Gas Permeable), Extended Wear
Updated June 16, 2023. 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.