510(k) Report

FDA applicant

Florida Optical Engineering, Inc.

Alachua, FL1 decision2001–20010 recalls

FDA records 1 decision for Florida Optical Engineering, Inc. (Alachua, FL) in 2001: 1 510(k) clearance. All are in product code LPL (Lenses, Soft Contact, Daily Wear). 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 Florida Optical Engineering, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Florida Optical Engineering, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • LPLLenses, Soft Contact, Daily Wear1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K013445Osprey Spherical and Toric Multifocal Soft Contact LensesFlorida Optical Engineering, Inc. · 20011cites it

What has FDA decided for it lately?

  • K013445Osprey Spherical and Toric Multifocal Soft Contact LensesFlorida Optical Engineering, Inc. · 2001

The one decision as Florida Optical Engineering, Inc. →