Danker Laboratories, Inc.
Country not established
- Devices
- 1
What Danker Laboratories, Inc. makes
Danker Laboratories, Inc. manufactures hard contact lenses made from cellulose acetate butyrate, designed for mesopic vision correction. These lenses are intended for extended wear and provide clear vision for patients requiring rigid gas-permeable optics.
The company’s portfolio is regulated under FDA’s Class II designation and requires Premarket Approval (PMA) authorisation. These devices are listed in the FDA’s PMA registry, adhering to US regulatory standards for contact lenses.
Catalogue
- Regimes: PMA Registry: PMA
Frequently asked questions
How many devices does Danker Laboratories, Inc. have in the registry?
The registry currently lists 1 device for Danker Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Danker Laboratories, Inc.'s devices?
Among its 1 most recently registered device, Danker Laboratories, Inc. has devices listed in FDA PMA (1 device).
What risk classes do Danker Laboratories, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Danker Laboratories, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Danker Laboratories, Inc. in the registry?
The most recently registered devices listed for Danker Laboratories, Inc. include MESO(CELLULOSE ACETATE BUTYRATE) HARD CONTACT LENS.