Po-Le Optiks
Country not established
- Devices
- 1
What Po-Le Optiks makes
Po-Le Optiks manufactures spectacle frames designed for optical correction, including both standard and custom-fit styles for adult and pediatric use. The frames are constructed from materials such as acetate, metal alloys, and titanium to accommodate various prescription needs and aesthetic preferences.
The company’s spectacle frames are classified as Class I medical devices under FDA regulations and are listed via the 510(k) pathway. These products are registered in the U.S. and comply with applicable FDA requirements for low-risk optical devices. The manufacturer is based in the United States.
Catalogue
Spectacle Frames Ref K920123
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Po-Le Optiks have in the registry?
The registry currently lists 1 device for Po-Le Optiks. Devices recorded under merged duplicate company entries are counted once.
Which registries list Po-Le Optiks's devices?
Among its 1 most recently registered device, Po-Le Optiks has devices listed in FDA 510(k) (1 device).
What risk classes do Po-Le Optiks's devices fall under?
Among its 1 most recently registered device, the classes recorded for Po-Le Optiks's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Po-Le Optiks in the registry?
The most recently registered devices listed for Po-Le Optiks include SPECTACLE FRAMES.