510(k) Report

FDA applicant

United Sonics, Inc.

Hauppauge, NY5 decisions1985–19850 recalls

FDA records 5 decisions for United Sonics, Inc. (Hauppauge, NY) in 1985: 5 510(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 United Sonics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for United Sonics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — United Sonics, 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, Phacofragmentation5decisions

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.

  • K851210United Sonics Phaco Module, DF-35United Sonics, Inc. · 19851cites it

What has FDA decided for it lately?

  • K851211Phaco Pak IUnited Sonics, Inc. · 1985
  • K851210United Sonics Phaco Module, DF-35United Sonics, Inc. · 1985
  • K851298Mid Labs MvsxiUnited Sonics, Inc. · 1985
  • K851209Cilco/United Sonics Phace PF-9000United Sonics, Inc. · 1985
  • K851212United Sonics Paco System Model 3000United Sonics, Inc. · 1985

All 5 as United Sonics, Inc. →