510(k) Report

FDA applicant

Optical Micro Systems, Inc.

Mchenry, IL21 decisions1981–19950 recalls

FDA records 21 decisions for Optical Micro Systems, Inc. (Mchenry, IL) from 1981 to 1995: 21 510(k) clearances. Most are in product codes HQE (Instrument, Vitreous Aspiration And Cutting…) and HQC (Unit, Phacofragmentation). 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 Optical Micro Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Optical Micro Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Optical”

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