Cleared Traditional

K150288 - PDO Absorbable Punctum Plug

K150288 · Riverpoint Medical · Ophthalmic device
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Optimized for regulatory review, auditing and printing
Aug 2015
Decision
204d
Days
-
Risk

K150288 is an FDA 510(k) clearance for the PDO Absorbable Punctum Plug. Classified as Plug, Punctum (product code LZU).

Submitted by Riverpoint Medical (Portland, US). The FDA issued a Cleared decision on August 28, 2015 after a review of 204 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 Riverpoint Medical devices

FDA 510(k) Submission Details - K150288

510(k) Number K150288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2015
Decision Date August 28, 2015
Days to Decision 204 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
94d slower than avg
Panel avg: 110d · This submission: 204d
Pathway characteristics
Predicate-based equivalence.

LZU Device Classification - Class 0,

Product Code LZU Plug, Punctum
Device Class -

Regulatory Peers - LZU Plug, Punctum

All 26
Devices cleared under the same product code (LZU) and FDA review panel - the closest regulatory comparables to K150288.
Tear Pool Dissolvable Punctum Plugs
K190210 · Alphamed, Inc. · Oct 2019
Soft Plug Extended Duration 180 Canalicular Plug
K162361 · Oasis Medical, Inc. · Apr 2017
LacriPro Punctum Plug
K161673 · Lacrimedics, Inc. · Nov 2016
VERAPLUG
K140352 · Krishna Imports Inc Dba Stephens Instruments · Nov 2014
COMFORTEAR LACRISOLVE ABSORBABLE PUNCTUM PLUG, LACRISOLVE ABSORBABLE PUNCTUM PLUG, COMFORTEAR LACRISOLVE PUNCTUM PLUG,
K140711 · Paragon Bioteck, Inc. · Jun 2014
COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST
K140026 · Lacrimedics, Inc. · Jun 2014