Cleared Traditional

K213988 - SOFT PLUG Extended Duration 180 Tapered Canalicular Plug (FDA 510(k) Clearance)

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.

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Submission Details

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.

Device Classification

Product Code LZU Plug, Punctum
Device Class -