FDA applicant
Vistakon, Johnson & Johnson Vision Products, Inc.
FDA records 9 decisions for Vistakon, Johnson & Johnson Vision Products, Inc. (Jacksonville, FL) from 1980 to 2000: 8 510(k) clearances and 1 original PMA approval. Most are in product codes LPL (Lenses, Soft Contact, Daily Wear) and LPM (Lenses, Soft Contact, Extended Wear). Its devices cite 4 predicates, 4 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Vistakon, Johnson & Johnson Vision Products, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Vistakon, Johnson & Johnson Vision Products, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Vistakon, Johnson & Johnson Vision…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Vistakon”
FDA records each applicant name separately; these may or may not be the same firm.