510(k) Report

FDA applicant

Tri-Star Ophthalmic

Liberty, MO2 decisions1991–19950 recalls

FDA records 2 decisions for Tri-Star Ophthalmic (Liberty, MO) from 1991 to 1995: 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 Tri-Star Ophthalmic’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Tri-Star Ophthalmic since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Tri-Star Ophthalmic 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

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.

  • K914229Phaco TipTri-Star Ophthalmic · 19911cites it

What has FDA decided for it lately?

  • K953359Tri-Star Universal I/a Phaco PakTri-Star Ophthalmic · 1995
  • K914229Phaco TipTri-Star Ophthalmic · 1991

All 2 as Tri-Star Ophthalmic →