Art Optical Contact Lens, Inc.
United Statesfrom the FDA registration address FDA establishment FEI 3002340631
- Devices
- 6
- Registrations
- FDA
- FDA recalls
- 0
What Art Optical Contact Lens, Inc. makes
ART OPTICAL CONTACT LENS, INC. makes soft contact lenses for daily wear, including silicone hydrogel and hydrogel materials, such as Intelliwave4, Intelliwave3, and Intelliwave lenses, as well as scleral rigid gas permeable (RGP) lenses under the Ampleye brand with various material designations including roflufocon D, roflufocon E, hexafocon A, and paflufocon D.
The company's devices are classified as Class II medical devices and are listed in the FDA 510(k) registry. The manufacturer is based in the United States.
Catalogue
Intelliwave4 Ref K142641
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
INTELLIWAVE3 Ref K100221
Regimes: 510(k) Registry: 510(k)Intelliwave, Soft Daily Wear Contact Lens (Acofilcon B) Hioxifilcon B) Clear And Blue Visibility Tint Ref K073621
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3002340631
- Address
- 3175 3 MILE RD. NW, Walker, MI, 49534
Frequently asked questions
How many devices does ART OPTICAL CONTACT LENS, INC. have in the registry?
The registry currently lists 6 devices for ART OPTICAL CONTACT LENS, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list ART OPTICAL CONTACT LENS, INC.'s devices?
Among its 6 most recently registered devices, ART OPTICAL CONTACT LENS, INC. has devices listed in FDA 510(k) (6 devices).
What risk classes do ART OPTICAL CONTACT LENS, INC.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for ART OPTICAL CONTACT LENS, INC.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from ART OPTICAL CONTACT LENS, INC. in the registry?
The most recently registered devices listed for ART OPTICAL CONTACT LENS, INC. include Intelliwave4, Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A), Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) and IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A).