Ocu-Ease Optical Products, Inc.
United StatesFDA applicant, unverified
- Devices
- 10
What Ocu-Ease Optical Products, Inc. makes
Ocu-Ease Optical Products, Inc. manufactures soft contact lenses for daily wear, including spherical, toric, aspherical, and custom prosthetic designs. Their portfolio includes lenses for specific conditions such as keratoconus, aphakia in pediatric patients, and thin zone toric variants. Materials used include polymacon, hioxifilcon B, ocufilcon B, and methafilcon A, with some lenses available in lathe-cut or tinted finishes. The company also supplies sterilized finished ocufilcon B lenses.
The company’s products are regulated as Class II medical devices under FDA pathways, including 510(k) and PMA submissions. These devices are listed in the FDA’s regulatory records, and the manufacturer is based in the United States.
Catalogue
Ocu-Flex-38 (Polymacon) Ref K941998
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Ocu-Flex Pediatric Aphakic (Ocufilcon B) Spherical Soft Contact Lens For Daily Wear (Lathe-Cut) Ref K023077
Regimes: 510(k) Registry: 510(k)Ocu-Flex-53 Thin Zone Toric And Thin Zone Toric Aspherical (Ocufilcon) Soft Contact Lenses For Daily Wear Ref K003996
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Sterilized Finished Ocufilcon B Lenses Ref P820051
Regimes: PMA Registry: PMA
Frequently asked questions
How many devices does Ocu-Ease Optical Products, Inc. have in the registry?
The registry currently lists 10 devices for Ocu-Ease Optical Products, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ocu-Ease Optical Products, Inc.'s devices?
Among its 10 most recently registered devices, Ocu-Ease Optical Products, Inc. has devices listed in FDA 510(k) (9 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Ocu-Ease Optical Products, Inc.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Ocu-Ease Optical Products, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ocu-Ease Optical Products, Inc. in the registry?
The most recently registered devices listed for Ocu-Ease Optical Products, Inc. include OCU-FLEX-38 (POLYMACON), OCU-FLEX-49 THIN ZONE TORIC AND THIN Z0NE TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR (LATHE-CUT, TINTED OCU-FLEX 53 (OCCUFILCON B) SOFT HYDROPHILIC CONTACT LENS and OCU-FLEX-49 SPHERICAL, TORIC, ASPHERICAL AND TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR.