510(k) Report

FDA applicant

Visionex, Inc.

Sunnyvale, CA2 decisions1988–19910 recalls

FDA records 2 decisions for Visionex, Inc. (Sunnyvale, CA) from 1988 to 1991: 2 510(k) clearances. Most are in product codes KYF (Implant, Eye Valve) and KYD (Strip, Schirmer). 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 Visionex, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Visionex, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Visionex, 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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