Australian Optical Co., Inc.
United StatesFDA applicant, unverified
- Devices
- 8
What Australian Optical Co., Inc. makes
Australian Optical Co., Inc. manufactures optical frames, including spectacle frames, sunglass frames, and sunglasses, as well as sunglass clips designed for eyewear.
These products are classified as Class I medical devices under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Optical Frame Ref K910179
Regimes: 510(k) Registry: 510(k)Spectacle Frame Ref K911332
Regimes: 510(k) Registry: 510(k)Sunglass Frame Ref K935678
Regimes: 510(k) Registry: 510(k)Spectacle Frame Ref K943561
Regimes: 510(k) Registry: 510(k)Spectacle Frame Ref K943641
Regimes: 510(k) Registry: 510(k)Spectacle Frame Ref K930331
Regimes: 510(k) Registry: 510(k)Sunglasses Ref K943562
Regimes: 510(k) Registry: 510(k)Sunglass Clip Ref K943640
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Australian Optical Co., Inc. have in the registry?
The registry currently lists 8 devices for Australian Optical Co., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Australian Optical Co., Inc.'s devices?
Among its 8 most recently registered devices, Australian Optical Co., Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Australian Optical Co., Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Australian Optical Co., Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Australian Optical Co., Inc. in the registry?
The most recently registered devices listed for Australian Optical Co., Inc. include OPTICAL FRAME, SPECTACLE FRAME, SUNGLASS FRAME and SUNGLASSES.