Cleared Traditional

K140026 - COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST

K140026 · Lacrimedics, Inc. · Ophthalmic device
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Jun 2014
Decision
148d
Days
-
Risk

K140026 is an FDA 510(k) clearance for the COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST. Classified as Plug, Punctum (product code LZU).

Submitted by Lacrimedics, Inc. (Du Pont, US). The FDA issued a Cleared decision on June 3, 2014 after a review of 148 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K140026

510(k) Number K140026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2014
Decision Date June 03, 2014
Days to Decision 148 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 110d · This submission: 148d
Pathway characteristics
Predicate-based equivalence.

LZU Device Classification - Class 0,

Product Code LZU Plug, Punctum
Device Class -

Regulatory Peers - LZU Plug, Punctum

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