Vistakon, Johnson & Johnson Vision Products, Inc.
United StatesFDA applicant, unverified
- Devices
- 8
What Vistakon, Johnson & Johnson Vision Products, Inc. makes
The company manufactures soft (hydrophilic) contact lenses designed for daily wear, including clear and visibility-tinted variants with UV blocker options. Their portfolio includes multifocal lenses and specific formulations such as Genfilcon A, Etafilcon A, and Lenefilcon A. Some products are marketed under brands like Vistakon and Acuvue.
These devices are classified as Class II under FDA regulations and are authorised via 510(k) clearances and PMA submissions. The manufacturer is based in the United States and their products are listed in the FDA’s regulatory databases.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Vistakon Multifocal (Etafilcon A) Contact Lens Ref K953804
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Acuvue (Etafilcon A) Soft (Hydrophilic) Contact Lens Clear And Visibility Tinted With Uv Blocker Ref K994324
Regimes: 510(k) Registry: 510(k)Hydro Marc Lenses (Hydrophilic) Ref N18033
Regimes: PMA Registry: PMA
Frequently asked questions
How many devices does Vistakon, Johnson & Johnson Vision Products, Inc. have in the registry?
The registry currently lists 8 devices for Vistakon, Johnson & Johnson Vision Products, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Vistakon, Johnson & Johnson Vision Products, Inc.'s devices?
Among its 8 most recently registered devices, Vistakon, Johnson & Johnson Vision Products, Inc. has devices listed in FDA 510(k) (7 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Vistakon, Johnson & Johnson Vision Products, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Vistakon, Johnson & Johnson Vision Products, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Vistakon, Johnson & Johnson Vision Products, Inc. in the registry?
The most recently registered devices listed for Vistakon, Johnson & Johnson Vision Products, Inc. include VISTAKON (LENEFILCON A)CONTACT LENS CLEAR AND VISIBILITY TINT WITH UV BLOCKER, VISTAKON (GENFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILIITY TINT, ACUVUE (ETAFILCON A)SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY TINT, WITH UV BLOCKER, FOR DAILY WEAR and ACUVUE (ETAFILCON A) CONTACT LENS CLEAR & W/VISIBILITY TINT W/UV BLOCKER.