FDA applicant

Optical Systems Intl., Inc.

Hialeah, FL2 decisions1985–19850 recalls

FDA records 2 decisions for Optical Systems Intl., Inc. (Hialeah, FL) in 1985: 2 510(k) clearances. Most are in product codes HQG (Lens, Spectacle, Non-Custom (Prescription)) and HRG (Engine, Trephine, Accessories, Ac-Powered). 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 Systems Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Optical Systems Intl., 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.

Optical Micro Systems, Inc. 21 Optical Sensors, Inc. 7 Optical Radiation Corp. 3 Optical Imaging, Ltd. 2 Optical Integrity, Inc. 2 Optical Connection, Inc. 2 Optical Polymer Research, Inc. 2 Optical Diagnostics, Inc. 1 Optical Center 1 Optical Moulding Systems 1 Optical Xpressions, Ltd. 1 Optical Coating Laboratory, Inc. 1

Optical Systems Intl., Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Optical”