510(k) Report

FDA applicant

Softfocal Company, Inc.

Moraga, CA1 decision2003–20030 recalls

FDA records 1 decision for Softfocal Company, Inc. (Moraga, CA) in 2003: 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 Softfocal Company, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Softfocal Company, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Softfocal Company, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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