510(k) Report

FDA applicant

Visant Medical, Inc.

Menlo Park, CA1 decision2022–20220 recalls

FDA records 1 decision for Visant Medical, Inc. (Menlo Park, CA) in 2022: 1 510(k) clearance. All are in product code LZU (Plug, Punctum). Its devices cite 1 predicate, 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

How often FDA has decided Visant Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2022: 1
2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Visant Medical, Inc. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Visant Medical, 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?

  • LZUPlug, Punctum1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K222164Visant Medical Canalicular PlugVisant Medical, Inc. · 2022

The one decision as Visant Medical, Inc. →