Xavier A. Guerra, Ocularist, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 2
What Xavier A. Guerra, Ocularist, Inc. makes
Xavier A. Guerra, Ocularist, Inc. manufactures scleral shells and ocular conformers, which are custom-fitted prosthetic devices designed to support the eye socket and improve comfort for patients with ocular or orbital deficiencies.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company operates within the United States.
Catalogue
Scleral Shell Ref K970320
510(k) 510(k)Ocular Conformer Ref K970319
510(k) 510(k)
Frequently asked questions
How many devices does Xavier A. Guerra, Ocularist, Inc. have in the registry?
The registry currently lists 2 devices for Xavier A. Guerra, Ocularist, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Xavier A. Guerra, Ocularist, Inc.'s devices?
Among its 2 most recently registered devices, Xavier A. Guerra, Ocularist, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Xavier A. Guerra, Ocularist, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Xavier A. Guerra, Ocularist, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Xavier A. Guerra, Ocularist, Inc. in the registry?
The most recently registered devices listed for Xavier A. Guerra, Ocularist, Inc. include SCLERAL SHELL and OCULAR CONFORMER.