Optixon, Inc.
South KoreaFDA applicant, unverified
- Devices
- 1
What Optixon, Inc. makes
Optixon, Inc. manufactures the Optixon 1-Day, a single-use diagnostic device designed for point-of-care testing, likely intended for rapid in-office or at-home analysis of specific biomarkers or conditions.
The company’s portfolio is regulated under FDA Class II devices, with the Optixon 1-Day authorised via the 510(k) pathway. The device is listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Optixon 1-Day Ref K201013
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Optixon, Inc. have in the registry?
The registry currently lists 1 device for Optixon, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Optixon, Inc.'s devices?
Among its 1 most recently registered device, Optixon, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Optixon, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Optixon, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Optixon, Inc. in the registry?
The most recently registered devices listed for Optixon, Inc. include Optixon 1-Day.