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FDA 510(k)

Tear Pool Dissolvable Punctum Plugs

K-Number: K190210 · 2019-10-24

ApplicantAlphamed, Inc.
Decision Date2019-10-24
Product CodeLZU
DecisionSubstantially Equivalent

Device Summary

Tear Pool Dissolvable Punctum Plugs is the device name listed in this FDA 510(k) record. The listed applicant is Alphamed, Inc.. It received FDA 510(k) clearance on 2019-10-24 under 510(k) number K190210. The device is classified under product code LZU. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tear Pool Dissolvable Punctum Plugs?

Tear Pool Dissolvable Punctum Plugs is a medical device that received FDA 510(k) clearance on 2019-10-24. The listed applicant is Alphamed, Inc.. The 510(k) number is K190210.

When did Tear Pool Dissolvable Punctum Plugs receive FDA 510(k) clearance?

Tear Pool Dissolvable Punctum Plugs received FDA 510(k) clearance on 2019-10-24, under 510(k) number K190210.

Who is the listed applicant for Tear Pool Dissolvable Punctum Plugs?

The FDA 510(k) record lists Alphamed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tear Pool Dissolvable Punctum Plugs?

The FDA product code for Tear Pool Dissolvable Punctum Plugs is LZU.

Related Devices (Code: LZU)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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