Optikos Shami, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Optikos Shami, Inc. makes
Optikos Shami, Inc. manufactures prescription and non-prescription sunglasses, as well as spectacle frames designed for general eyewear use.
The company’s products are classified as Class I medical devices under FDA regulations and are listed via the 510(k) pathway. The portfolio is based in the United States.
Catalogue
Optikos Shami, Inc. Sunglasses Ref K934197
Regimes: 510(k) Registry: 510(k)Optikos Shami, Inc. Spectacle Frames Ref K934198
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Optikos Shami, Inc. have in the registry?
The registry currently lists 2 devices for Optikos Shami, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Optikos Shami, Inc.'s devices?
Among its 2 most recently registered devices, Optikos Shami, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Optikos Shami, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Optikos Shami, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Optikos Shami, Inc. in the registry?
The most recently registered devices listed for Optikos Shami, Inc. include OPTIKOS SHAMI, INC. SUNGLASSES and OPTIKOS SHAMI, INC. SPECTACLE FRAMES.