Cleared Traditional

K213988 - SOFT PLUG Extended Duration 180 Tapered...

K213988 · Oasis Medical, Inc. · Ophthalmic device
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Jun 2022
Decision
165d
Days
-
Risk

K213988 is an FDA 510(k) clearance for the SOFT PLUG Extended Duration 180 Tapered Canalicular Plug. Classified as Plug, Punctum (product code LZU).

Submitted by Oasis Medical, Inc. (Glendora, US). The FDA issued a Cleared decision on June 3, 2022 after a review of 165 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 Oasis Medical, Inc. devices

FDA 510(k) Submission Details - K213988

510(k) Number K213988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2021
Decision Date June 03, 2022
Days to Decision 165 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
55d slower than avg
Panel avg: 110d · This submission: 165d
Pathway characteristics
Predicate-based equivalence.

LZU Device Classification - Class 0,

Product Code LZU Plug, Punctum
Device Class -

Regulatory Peers - LZU Plug, Punctum

All 7
Devices cleared under the same product code (LZU) and FDA review panel - the closest regulatory comparables to K213988.
Hello,eyes® BIO Plug
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Visant Medical Canalicular Plug
K222164 · Visant Medical, Inc. · Dec 2022
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K190210 · Alphamed, Inc. · Oct 2019
PDO Absorbable Punctum Plug
K150288 · Riverpoint Medical · Aug 2015
VISITEC COLLAR BUTTON CATHETER {GRIFFITHS}
K953394 · Visitec Co. · Oct 1995
VISITEC CANALICULAR STENT
K915809 · Visitec Co. · Feb 1992