Cleared Traditional

K140711 - COMFORTEAR LACRISOLVE ABSORBABLE PUNCTUM PLUG, LACRISOLVE ABSORBABLE PUNCTUM PLUG, COMFORTEAR LACRISOLVE PUNCTUM PLUG,

K140711 · Paragon Bioteck, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2014
Decision
91d
Days
-
Risk

K140711 is an FDA 510(k) clearance for the COMFORTEAR LACRISOLVE ABSORBABLE PUNCTUM PLUG, LACRISOLVE ABSORBABLE PUNCTUM .... Classified as Plug, Punctum (product code LZU).

Submitted by Paragon Bioteck, Inc. (Portland, US). The FDA issued a Cleared decision on June 20, 2014 after a review of 91 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.

FDA 510(k) Submission Details - K140711

510(k) Number K140711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2014
Decision Date June 20, 2014
Days to Decision 91 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
19d faster than avg
Panel avg: 110d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

LZU Device Classification - Class 0,

Product Code LZU Plug, Punctum
Device Class -

Regulatory Peers - LZU Plug, Punctum

All 45
Devices cleared under the same product code (LZU) and FDA review panel - the closest regulatory comparables to K140711.
LacriPro Punctum Plug
K161673 · Lacrimedics, Inc. · Nov 2016
PDO Absorbable Punctum Plug
K150288 · Riverpoint Medical · Aug 2015
VERAPLUG
K140352 · Krishna Imports Inc Dba Stephens Instruments · Nov 2014
COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST
K140026 · Lacrimedics, Inc. · Jun 2014
FLOW CONTROLLER
K090938 · Odyssey Medical, Inc. · Jun 2009
SNUG PLUG PUNCTUM PLUG
K061398 · Fci Ophthalmics, Inc. · Jul 2006
K140711 · COMFORTEAR LACRISOLVE ABSORBABLE PUNCTUM PLUG, LACRISOLVE ABSORBABLE PUNCTUM PLUG, COMFORTEAR LACRISOLVE PUNCTUM PLUG,
Download PDF FDA Summary Paragon Bioteck, Inc.