South American Optical, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What South American Optical, Inc. makes
South American Optical, Inc. manufactures non-prescription spectacle sun glasses and spectacle frames designed for general eye protection and fashion use.
These products are classified as Class I medical devices under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Spectacle Sun Glasses (Non Prescription) Ref K934081
Regimes: 510(k) Registry: 510(k)Spectacle Frames Ref K934082
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does South American Optical, Inc. have in the registry?
The registry currently lists 2 devices for South American Optical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list South American Optical, Inc.'s devices?
Among its 2 most recently registered devices, South American Optical, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do South American Optical, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for South American Optical, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from South American Optical, Inc. in the registry?
The most recently registered devices listed for South American Optical, Inc. include SPECTACLE SUN GLASSES (NON PRESCRIPTION) and SPECTACLE FRAMES.