510(k) Report

FDA applicant

Nissel, Ltd.

Chicago, IL2 decisions1992–19990 recalls

FDA records 2 decisions for Nissel, Ltd. (Chicago, IL) from 1992 to 1999: 2 510(k) clearances. Most are in product codes LPL (Lenses, Soft Contact, Daily Wear) and HQH (Eye, Artificial, Non-Custom). Its devices cite 2 predicates, 0 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 Nissel, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Nissel, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Nissel, Ltd.’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