Cool Eyes, Inc.
CanadaFDA applicant, unverified
- Devices
- 1
What Cool Eyes, Inc. makes
Cool Eyes, Inc. manufactures the COOL EYE™ EYE PROTECTOR, a device designed to shield the eyes from direct sunlight and reduce glare during outdoor activities.
The COOL EYE™ EYE PROTECTOR is classified as a Class I medical device in the U.S. and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Cool Eye(Tm) Eye Protector Ref K881135
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cool Eyes, Inc. have in the registry?
The registry currently lists 1 device for Cool Eyes, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cool Eyes, Inc.'s devices?
Among its 1 most recently registered device, Cool Eyes, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Cool Eyes, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Cool Eyes, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Cool Eyes, Inc. in the registry?
The most recently registered devices listed for Cool Eyes, Inc. include COOL EYE(TM) EYE PROTECTOR.