FDA applicant

Fibra Sonics, Inc.

Chicago, IL10 decisions1980–19990 recalls

FDA records 10 decisions for Fibra Sonics, Inc. (Chicago, IL) from 1980 to 1999: 10 510(k) clearances. Most are in product codes HQC (Unit, Phacofragmentation) and LFL (Instrument, Ultrasonic Surgical). 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 Fibra Sonics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

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Fibra Sonics, Inc.

Which product codes does it file in?

What has FDA decided for it lately?