Ophthalmos, Ltd.
United KingdomFDA applicant, unverified
- Devices
- 1
What Ophthalmos, Ltd. makes
Ophthalmos, Ltd. manufactures the OPTYSE ophthalmoscope, a diagnostic device used for examining the interior structures of the eye, including the retina, optic disc, blood vessels, and posterior pole.
The OPTYSE ophthalmoscope is classified as a Class II medical device under FDA regulations and is authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
Optyse Ophthalmoscope Ref K061278
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ophthalmos, Ltd. have in the registry?
The registry currently lists 1 device for Ophthalmos, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ophthalmos, Ltd.'s devices?
Among its 1 most recently registered device, Ophthalmos, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Ophthalmos, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Ophthalmos, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ophthalmos, Ltd. in the registry?
The most recently registered devices listed for Ophthalmos, Ltd. include OPTYSE OPHTHALMOSCOPE.