Visant Medical Canalicular Plug— 510(k) K222164

Name: FDA 510(k) clearance K222164
Creator: U.S. Food and Drug Administration
Published: 2022-12-23

Substantially Equivalent

Visant Medical, Inc.

FDA 510(k) clearance K222164 for Visant Medical Canalicular Plug, Substantially Equivalent on 2022-12-23. Applicant: Visant Medical, Inc.. Device class: Unclassified.

Clearance details

Applicant: Visant Medical, Inc.
Product code: Code LZU
Device class: Unclassified
Advisory panel: Unknown
Date received: 2022-07-21
Decision date: 2022-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Menlo Park, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LZU

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K241229 — Hello,eyes® BIO Plug2024-06-28
K213988 — SOFT PLUG Extended Duration 180 Tapered Canalicular Plug2022-06-03
K190210 — Tear Pool Dissolvable Punctum Plugs2019-10-24
K162361 — Soft Plug Extended Duration 180 Canalicular Plug2017-04-17
K161673 — LacriPro Punctum Plug2016-11-18

Adverse events under product code LZU

product code LZU

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.