Southwest Artificial Eyes, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Southwest Artificial Eyes, Inc. makes
Southwest Artificial Eyes, Inc. manufactures scleral shells and ocular conformers, which are custom-fitted prosthetic devices designed to support and stabilize the eye socket for patients with ocular prostheses or severe eye loss.
These devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. The company operates from the United States.
Catalogue
Scleral Shell Ref K970327
Regimes: 510(k) Registry: 510(k)Ocular Conformer Ref K970318
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Southwest Artificial Eyes, Inc. have in the registry?
The registry currently lists 2 devices for Southwest Artificial Eyes, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Southwest Artificial Eyes, Inc.'s devices?
Among its 2 most recently registered devices, Southwest Artificial Eyes, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Southwest Artificial Eyes, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Southwest Artificial Eyes, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Southwest Artificial Eyes, Inc. in the registry?
The most recently registered devices listed for Southwest Artificial Eyes, Inc. include SCLERAL SHELL and OCULAR CONFORMER.