Optical Systems Intl., Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Optical Systems Intl., Inc. makes
Optical Systems Intl., Inc. manufactures contact lenses, including the ULTRATHIN/SP LENS and THE ULTRA-MATE LENS, designed for ocular correction.
These devices are classified as Class I under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Ultrathin/Sp Lens Ref K843957
Regimes: 510(k) Registry: 510(k)The Ultra-Mate Lens Ref K854218
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Optical Systems Intl., Inc. have in the registry?
The registry currently lists 2 devices for Optical Systems Intl., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Optical Systems Intl., Inc.'s devices?
Among its 2 most recently registered devices, Optical Systems Intl., Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Optical Systems Intl., Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Optical Systems Intl., Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Optical Systems Intl., Inc. in the registry?
The most recently registered devices listed for Optical Systems Intl., Inc. include ULTRATHIN/SP LENS and THE ULTRA-MATE LENS.