American Biocurve, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What American Biocurve, Inc. makes
American Biocurve, Inc. manufactures spherical and toric soft contact lenses designed for daily wear, including versions with clear and blue visibility tints. Their product line includes lenses made from methafilcon A and hi-oxifilcon B materials, catering to vision correction needs with both standard and enhanced handling properties.
The company’s devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. Their products are listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does American Biocurve, Inc. have in the registry?
The registry currently lists 2 devices for American Biocurve, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list American Biocurve, Inc.'s devices?
Among its 2 most recently registered devices, American Biocurve, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do American Biocurve, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for American Biocurve, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from American Biocurve, Inc. in the registry?
The most recently registered devices listed for American Biocurve, Inc. include BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR & BLUE VISIBILITY TINT, LATHE and BIOCURVE SOFT (HIOXIFILCON B) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND BLUE VISIBILITY-HANDLING L.