Optech, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Optech, Inc. makes
Optech, Inc. manufactures soft contact lenses for daily wear, including multifocal designs such as the POLVUE MULTIFOCAL (Polymacon) and POLVUE 43 (Ocufilcon A), as well as spherical, toric, and aspherical variants. Their product line also includes the OPTECH Fre-Flex soft contact lens, designed for extended comfort and vision correction.
These devices are classified as Class II under FDA regulations and are supported by 510(k) and PMA pathways. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Optech Fre-Flex Soft Contact Lens Ref P810050
Regimes: PMA Registry: PMA
Frequently asked questions
How many devices does Optech, Inc. have in the registry?
The registry currently lists 3 devices for Optech, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Optech, Inc.'s devices?
Among its 3 most recently registered devices, Optech, Inc. has devices listed in FDA 510(k) (2 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Optech, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Optech, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Optech, Inc. in the registry?
The most recently registered devices listed for Optech, Inc. include POLVUE MULTIFOCAL (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND VISIBILITY TINTED, FULLY CAST-MOLDED LENS), POLYVUE 43 (OCUFILCON A) SPHERICAL, TORIC AND ASPHERICAL MULTIFOCAL HYDROPHILIC CONTACT LENSES FOR DAILY WEAR and OPTECH FRE-FLEX SOFT CONTACT LENS.