510(k) Report

FDA applicant

Odyssey Technologies, Inc.

Temple City, CA2 decisions1997–19970 recalls

FDA records 2 decisions for Odyssey Technologies, Inc. (Temple City, CA) in 1997: 2 510(k) clearances. All are in product code 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 Odyssey Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Odyssey Technologies, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Odyssey Technologies, 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?

  • HQCUnit, Phacofragmentation2decisions

What has FDA decided for it lately?

  • K972253P3 Universal Phaco HandpieceOdyssey Technologies, Inc. · 1997
  • K972252Vista Universal HandpieceOdyssey Technologies, Inc. · 1997

All 2 as Odyssey Technologies, Inc. →

Other applicant names beginning “Odyssey”

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

Odyssey Medical, Inc. 4Odyssey Medical Technologies 1Odyssey Optical Systems, LLC 1