510(k) Report

FDA applicant

Paragon Optical Co.

Mchenry, IL2 decisions1981–19860 recalls

FDA records 2 decisions for Paragon Optical Co. (Mchenry, IL) from 1981 to 1986: 1 510(k) clearance and 1 original PMA approval. Most are in product codes HPX (Lens, Contact (Polymethylmethacrylate)) and MWL (Lens, Contact (Rigid Gas Permeable), Extended…). 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 Paragon Optical Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Paragon Optical Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Paragon”

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