Polydev, Ltd.
IrelandFDA applicant, unverified
- Devices
- 3
What Polydev, Ltd. makes
Polydev, Ltd. manufactures soft contact lenses, including those made with hioxifilcon D material, designed for vision correction and ocular comfort.
The company’s portfolio consists of Class II devices, regulated under the FDA’s 510(k) pathway, and is based in the United States.
Catalogue
Toricolors (hioxifilcon D) Soft Contact Lenses Ref K161931
Regimes: 510(k) Registry: 510(k)PolyDev Soft Contact Lenses Ref K160977
Regimes: 510(k) Registry: 510(k)PolyDev Soft Contact Lenses Ref K171157
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Polydev, Ltd. have in the registry?
The registry currently lists 3 devices for Polydev, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Polydev, Ltd.'s devices?
Among its 3 most recently registered devices, Polydev, Ltd. has devices listed in FDA 510(k) (3 devices).
What risk classes do Polydev, Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Polydev, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Polydev, Ltd. in the registry?
The most recently registered devices listed for Polydev, Ltd. include Toricolors (hioxifilcon D) Soft Contact Lenses and PolyDev Soft Contact Lenses.