Tear Pool Dissolvable Punctum Plugs— 510(k) K190210

Substantially Equivalent

Alphamed, Inc.

FDA 510(k) clearance K190210 for Tear Pool Dissolvable Punctum Plugs, Substantially Equivalent on 2019-10-24. Applicant: Alphamed, Inc..

Clearance details

Applicant: Alphamed, Inc.
Product code: Code LZU
Advisory panel: Unknown
Date received: 2019-02-04
Decision date: 2019-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: El Paso, TX, US

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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.