Data / Medical devices / Japan / Tomey Corporation
Tomey Corporation: FDA-registered device maker in NAGOYA Aichi, Japan, 3 510(k) clearances
Tomey Corporation is registered with the FDA (registration 9614730) in NAGOYA Aichi, Japan. It lists 6 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 18, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9614730
- FEI number
- 3002680900
- Address
- 2-11-33 Noritakeshinmachi, Nishi-ku, NAGOYA Aichi, Japan, 451-0051
- Owner or operator
- TOMEY CORPORATION (9025937)
- Roles
- Manufacturer
- First device listed
- January 13, 2004
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Instrument, Measuring, Lens, Ac-Powered | HLM | 1 | Manufacturer | accessdata.fda.gov |
| Microscope, Specular | NQE | 2 | Manufacturer | accessdata.fda.gov |
| Refractometer, Ophthalmic | HKO | 1 | Manufacturer | accessdata.fda.gov |
| Tomography, Optical Coherence | OBO | 2 | Manufacturer | accessdata.fda.gov |
| Tonometer, Ac-Powered | HKX | 2 | Manufacturer | accessdata.fda.gov |
| Topographer, Corneal, Ac-Powered | MMQ | 1 | 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 |
|---|---|---|---|---|---|---|
| July 18, 2025 | K250553 | Tomey Cornea/Anterior Segment OCT (CASIA2) | OBO | Substantially Equivalent | Tomey Corporation | accessdata.fda.gov |
| January 19, 2018 | K171313 | EM-4000 Specular Microscope | NQE | Substantially Equivalent | Tomey Corporation | accessdata.fda.gov |
| November 18, 2008 | K073087 | NON-CONTACT TONOMETER, MODEL FT-1000 | HKX | Substantially Equivalent | Tomey Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Tonometer, Ac-Powered
- All makers of Instrument, Measuring, Lens, Ac-Powered
- All makers of Topographer, Corneal, Ac-Powered
- All makers of Tomography, Optical Coherence
- All makers of Microscope, Specular
- All makers of Refractometer, Ophthalmic
Updated July 18, 2025. 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.