510(k) Report

FDA applicant

Odyssey Optical Systems, LLC

Weston, FL1 decision1998–19980 recalls

FDA records 1 decision for Odyssey Optical Systems, LLC (Weston, FL) in 1998: 1 510(k) clearance. All are in product code HLI (Ophthalmoscope, 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 Odyssey Optical Systems, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Odyssey Optical Systems, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Odyssey Optical Systems, LLC’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

Which product codes does it file in?

  • HLIOphthalmoscope, Ac-Powered1decision

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.

  • K981640S2LOOdyssey Optical Systems, LLC · 19981cites it

What has FDA decided for it lately?

  • K981640S2LOOdyssey Optical Systems, LLC · 1998

The one decision as Odyssey Optical Systems, LLC →

Other applicant names beginning “Odyssey”

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

Odyssey Medical, Inc. 4Odyssey Technologies, Inc. 2Odyssey Medical Technologies 1