Data / Medical devices / Japan / santec OIS Corporation
santec OIS Corporation: FDA-registered device maker in Komaki Aichi, Japan, 2 510(k) clearances
santec OIS Corporation is registered with the FDA (registration 3012423824) in Komaki Aichi, Japan. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 16, 2019. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3012423824
- Address
- 5823 Ohkusa-Nenjozaka, Komaki Aichi, Japan, 4850802
- Owner or operator
- Santec Photonics Laboratory / Movu (10050106)
- Roles
- Manufacturer
- First device listed
- October 13, 2015
- Registered through
- 2027
- Brand names listed
- ARGOS, ARGOS ver 1.5
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Biomicroscope, Slit-Lamp, Ac-Powered | HJO | 2 | Manufacturer | accessdata.fda.gov |
| Device, Analysis, Anterior Segment | MXK | 2 | 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 |
|---|---|---|---|---|---|---|
| May 16, 2019 | K191051 | ARGOS | MXK | Substantially Equivalent | Santec Corporation | accessdata.fda.gov |
| October 2, 2015 | K150754 | ARGOS | MXK | Substantially Equivalent | Santec Corporation | accessdata.fda.gov |
Compare with other makers
Updated May 16, 2019. 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.