Blue Gem Sunglasses, Inc.
Country not established
- Devices
- 1
What Blue Gem Sunglasses, Inc. makes
Blue Gem Sunglasses, Inc. manufactures prescription and non-prescription sunglasses designed for UV protection and general eyewear use, including polarized and tinted lenses for various outdoor and daily activities.
The company’s products are classified as Class I medical devices under FDA regulations and are listed via the 510(k) pathway. The manufacturer operates from the United States.
Catalogue
Sunglasses Ref K941084
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Blue Gem Sunglasses, Inc. have in the registry?
The registry currently lists 1 device for Blue Gem Sunglasses, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Blue Gem Sunglasses, Inc.'s devices?
Among its 1 most recently registered device, Blue Gem Sunglasses, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Blue Gem Sunglasses, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Blue Gem Sunglasses, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Blue Gem Sunglasses, Inc. in the registry?
The most recently registered devices listed for Blue Gem Sunglasses, Inc. include SUNGLASSES.