510(k) Report

FDA applicant

Wesley Jessen Corp.

Des Plaines, IL11 decisions1987–20000 recalls

FDA records 11 decisions for Wesley Jessen Corp. (Des Plaines, IL) from 1987 to 2000: 11 510(k) clearances. Most are in product codes LPL (Lenses, Soft Contact, Daily Wear) and LPN (Accessories, Soft Lens Products). Its devices cite 7 predicates, 2 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, last Nov 3, 2026

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

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

FDA decisions per year

No FDA decision for Wesley Jessen Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Wesley Jessen Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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