Tony Optical Enterprises Co., Ltd.
TaiwanFDA applicant, unverified
- Devices
- 1
What Tony Optical Enterprises Co., Ltd. makes
Tony Optical Enterprises Co., Ltd. manufactures sunglasses designed for general eye protection and UV radiation blocking.
The company’s products are classified as Class I medical devices under FDA regulations and are listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Sunglasses Ref K950526
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Tony Optical Enterprises Co., Ltd. have in the registry?
The registry currently lists 1 device for Tony Optical Enterprises Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Tony Optical Enterprises Co., Ltd.'s devices?
Among its 1 most recently registered device, Tony Optical Enterprises Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Tony Optical Enterprises Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Tony Optical Enterprises Co., Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Tony Optical Enterprises Co., Ltd. in the registry?
The most recently registered devices listed for Tony Optical Enterprises Co., Ltd. include SUNGLASSES.