Data / Medical devices / United States / Oculus, Inc.
Oculus, Inc.: FDA-registered device maker in Arlington, WA, United States, 6 510(k) clearances
Oculus, Inc. is registered with the FDA (registration 3033566) in Arlington, WA, United States. It lists 21 device types. The FDA files 6 510(k) clearances under its listings, the newest dated March 13, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3033566
- FEI number
- 3002785343
- Address
- 17721 59th Avenue NE, Arlington, WA, United States, 98223
- Owner or operator
- OCULUS OPTIKGERATE GMBH (8010318)
- Roles
- Complaint file establishment
- First device listed
- April 20, 1978
- Registered through
- 2026
- Brand names listed
- Anomaloscope, Binoptometer, Binoptometer 4P, C-Quant, Centerfield 2, Chart, Visual Acuity, Color Vision Tester, Corvis STL and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| March 13, 2026 | K251848 | Pentacam® Cornea OCT | MXK | Substantially Equivalent | Oculus Optikgeräte GmbH | accessdata.fda.gov |
| July 14, 2021 | K202989 | Myopia Master | MXK | Substantially Equivalent | Oculus Optikgeräte GmbH | accessdata.fda.gov |
| October 21, 2020 | K201724 | Pentacam AXL Wave | MXK | Substantially Equivalent | Oculus Optikgerate GmbH | accessdata.fda.gov |
| January 20, 2016 | K152311 | Pentacam AXL | MXK | Substantially Equivalent | Oculus Optikgerate GmbH | accessdata.fda.gov |
| November 8, 2012 | K113066 | CORVIS ST | HKX | Substantially Equivalent | Oculus Optikgerate GmbH | accessdata.fda.gov |
| September 16, 2003 | K030719 | PENTACAM SCHEIMPFLUG CAMERA | MXK | Substantially Equivalent | Oculus Optikgerate GmbH | accessdata.fda.gov |
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Updated March 13, 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.