510(k) Report

FDA applicant

Visijet, Inc.

Irvine, CA1 decision2000–20000 recalls

FDA records 1 decision for Visijet, Inc. (Irvine, CA) in 2000: 1 510(k) clearance. All are in product code MYD (Keratome, Water Jet). Its devices cite 3 predicates, 0 of them its own earlier devices. 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 Visijet, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Visijet, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Which product codes does it file in?

  • MYDKeratome, Water Jet1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K991124Visijet Hydrokeratome, Model 50Visijet, Inc. · 2000

The one decision as Visijet, Inc. →