Cleared Traditional

K161673 - LacriPro Punctum Plug (FDA 510(k) Clearance)

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

K161673 is an FDA 510(k) clearance for the LacriPro Punctum Plug. Classified as Plug, Punctum (product code LZU).

Submitted by Lacrimedics, Inc. (Dupont, US). The FDA issued a Cleared decision on November 18, 2016 after a review of 155 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Lacrimedics, Inc. devices

Submission Details

510(k) Number K161673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 110d · This submission: 155d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZU Plug, Punctum
Device Class -