Cleared Traditional

Tear Pool Dissolvable Punctum Plugs

K190210 · Alphamed, Inc. · Ophthalmic

Oct 2019

Decision

262d

Days

—

Risk

About This 510(k) Submission

K190210 is an FDA 510(k) clearance for the Tear Pool Dissolvable Punctum Plugs, a Plug, Punctum, submitted by Alphamed, Inc. (El Paso, US). The FDA issued a Cleared decision on October 24, 2019, 262 days after receiving the submission on February 4, 2019. This device falls under the Ophthalmic review panel.

Submission Details

510(k) Number	K190210 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 04, 2019
Decision Date	October 24, 2019
Days to Decision	262 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF