C&E GP Specialist, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 2
What C&E GP Specialist, Inc. makes
C&E GP Specialist, Inc. manufactures orthokeratology contact lenses, specifically the iSee line made from roflufocon D and roflufocon E materials, designed for daily wear to temporarily reshape the cornea and correct refractive error.
These devices are classified as Class II medical devices and are listed in the FDA 510(k) registry; the company is based in the United States.
Catalogue
Isight Ref K121519
510(k) 510(k)- 510(k) 510(k)
Frequently asked questions
How many devices does C&E GP Specialist, Inc. have in the registry?
The registry currently lists 2 devices for C&E GP Specialist, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list C&E GP Specialist, Inc.'s devices?
Among its 2 most recently registered devices, C&E GP Specialist, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do C&E GP Specialist, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for C&E GP Specialist, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from C&E GP Specialist, Inc. in the registry?
The most recently registered devices listed for C&E GP Specialist, Inc. include ISIGHT and iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses.