Cleared Traditional

Visant Medical Canalicular Plug

K222164 · Visant Medical, Inc. · Ophthalmic

Dec 2022

Decision

155d

Days

—

Risk

About This 510(k) Submission

K222164 is an FDA 510(k) clearance for the Visant Medical Canalicular Plug, a Plug, Punctum, submitted by Visant Medical, Inc. (Menlo Park, US). The FDA issued a Cleared decision on December 23, 2022, 155 days after receiving the submission on July 21, 2022. This device falls under the Ophthalmic review panel.

Submission Details

510(k) Number	K222164 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 21, 2022
Decision Date	December 23, 2022
Days to Decision	155 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF