Paragon Optical Co.
Country not established
- Devices
- 2
What Paragon Optical Co. makes
Paragon Optical Co. manufactures rigid gas-permeable contact lenses, including the Paraperm E.W. Blue series, as well as contact lens materials designed for extended or daily wear. These products are intended for vision correction and ocular health applications, providing durable and oxygen-permeable solutions for patients.
The company’s portfolio is regulated under FDA classifications, with devices authorised via 510(k) clearances and Premarket Approval (PMA) applications. These products are listed in the U.S. regulatory system and fall under Class II and Class III (U) device categories, depending on the specific product type.
Catalogue
Contact Lens Materl Ref K811010
Regimes: 510(k) Registry: 510(k)- Regimes: PMA, withdrawn Registry: PMA
Frequently asked questions
How many devices does Paragon Optical Co. have in the registry?
The registry currently lists 2 devices for Paragon Optical Co.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Paragon Optical Co.'s devices?
Among its 2 most recently registered devices, Paragon Optical Co. has devices listed in FDA 510(k) (1 device) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Paragon Optical Co.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Paragon Optical Co.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Paragon Optical Co. in the registry?
The most recently registered devices listed for Paragon Optical Co. include CONTACT LENS MATERL and PARAPERM E.W. BLUE RIGID GAS PERMEABLE CONTACT LEN.