Optimed, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Optimed, Inc. makes
Optimed, Inc. manufactures diagnostic and monitoring devices for ophthalmology, including automated visual field testers (OptiField I and II), a corneal topography system (ECT-100), and a glaucoma pressure regulator. These tools are designed for assessing and managing eye conditions such as glaucoma and corneal health.
The company’s products are regulated under FDA’s 510(k) pathway, with devices classified as Class I and Class II. The portfolio is listed in the FDA’s 510(k) clearance registry, and the manufacturer is based in the United States.
Catalogue
Optifield I And Ii Automated Perimeters Ref K884867
Regimes: 510(k) Registry: 510(k)Optimed Advantage Ref K883458
Regimes: 510(k) Registry: 510(k)Ect-100 Electronic Corneal Topographer Ref K890687
Regimes: 510(k) Registry: 510(k)Optimed Glaucoma Pressure Regulator Ref K903462
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Optimed, Inc. have in the registry?
The registry currently lists 4 devices for Optimed, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Optimed, Inc.'s devices?
Among its 4 most recently registered devices, Optimed, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Optimed, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Optimed, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Optimed, Inc. in the registry?
The most recently registered devices listed for Optimed, Inc. include OPTIFIELD I AND II AUTOMATED PERIMETERS, OPTIMED ADVANTAGE, ECT-100 ELECTRONIC CORNEAL TOPOGRAPHER and OPTIMED GLAUCOMA PRESSURE REGULATOR.