Optimaxx Intl.
Country not established
- Devices
- 1
What Optimaxx Intl. makes
Optimaxx Intl. manufactures prescription and non-prescription sunglasses, including models such as NORMA, KAMLALI, ALFRED SUNG, ROOTS OF CANADA, and STEEL MAXX. These products are designed for UV protection and general eyewear use, catering to both fashion and functional needs.
The company’s sunglasses fall under FDA Class I medical devices, regulated via the 510(k) clearance process in the United States. The portfolio is listed in the FDA’s 510(k) database, reflecting compliance with US regulatory requirements. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Optimaxx Intl. have in the registry?
The registry currently lists 1 device for Optimaxx Intl.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Optimaxx Intl.'s devices?
Among its 1 most recently registered device, Optimaxx Intl. has devices listed in FDA 510(k) (1 device).
What risk classes do Optimaxx Intl.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Optimaxx Intl.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Optimaxx Intl. in the registry?
The most recently registered devices listed for Optimaxx Intl. include NORMA KAMLALI/ALFRED SUNG/ROOTS OF CANADA/STEEL MAXX SUNGLASS.