Orbtek, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Orbtek, Inc. makes
Orbtek, Inc. manufactures keratometers, including the ORBSCAN™ and ORBSHOT models, which measure corneal curvature for ophthalmic applications.
These devices are classified as Class I under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Orbscan(Tm) Keratometer Ref K940647
Regimes: 510(k) Registry: 510(k)Orbshot Keratometer Ref K964891
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Orbtek, Inc. have in the registry?
The registry currently lists 2 devices for Orbtek, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Orbtek, Inc.'s devices?
Among its 2 most recently registered devices, Orbtek, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Orbtek, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Orbtek, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Orbtek, Inc. in the registry?
The most recently registered devices listed for Orbtek, Inc. include ORBSCAN(TM) KERATOMETER and ORBSHOT KERATOMETER.