510(k) Report

FDA applicant

Cal Bionics

Novato, CA1 decision1996–19960 recalls

FDA records 1 decision for Cal Bionics (Novato, CA) in 1996: 1 510(k) clearance. All are in product code LPL (Lenses, Soft Contact, Daily Wear). 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 Cal Bionics’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cal Bionics since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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