FDA applicant

Vistakon

Jacksonville, FL5 decisions2001–20043 recalls

FDA records 5 decisions for Vistakon (Jacksonville, FL) from 2001 to 2004: 5 510(k) clearances. All are in product code LPL (Lenses, Soft Contact, Daily Wear). Its devices cite 4 predicates, 0 of them its own earlier devices. 3 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Vistakon’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Vistakon since 2007.

Recalls per year

1in 2019

2007high 2 (2017) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Vistakon by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Vistakon’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) Report

Other applicant names beginning “Vistakon”

FDA records each applicant name separately; these may or may not be the same firm.

Vistakon, Johnson & Johnson Vision Products, Inc. 9 Vistakon, Division of Johnson & Johnson Vision Car 1

Vistakon

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Vistakon”