Isohyper
Country not established
- Devices
- 1
What Isohyper makes
Isohyper manufactures UV-blocking sunglasses designed to protect the eyes from harmful solar radiation, including UVA and UVB rays.
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
Sunglasses Ref K952890
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Isohyper have in the registry?
The registry currently lists 1 device for Isohyper. Devices recorded under merged duplicate company entries are counted once.
Which registries list Isohyper's devices?
Among its 1 most recently registered device, Isohyper has devices listed in FDA 510(k) (1 device).
What risk classes do Isohyper's devices fall under?
Among its 1 most recently registered device, the classes recorded for Isohyper's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Isohyper in the registry?
The most recently registered devices listed for Isohyper include SUNGLASSES.