Cleared Traditional

LacriPro Punctum Plug

K161673 · Lacrimedics, Inc. · Ophthalmic
Nov 2016
Decision
155d
Days
—
Risk

About This 510(k) Submission

K161673 is an FDA 510(k) clearance for the LacriPro Punctum Plug, a Plug, Punctum, submitted by Lacrimedics, Inc. (Dupont, US). The FDA issued a Cleared decision on November 18, 2016, 155 days after receiving the submission on June 16, 2016. This device falls under the Ophthalmic review panel.

Submission Details

510(k) Number K161673 FDA.gov
FDA Decision Cleared SESE
Date Received June 16, 2016
Decision Date November 18, 2016
Days to Decision 155 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code LZU — Plug, Punctum
Device Class —

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