Cleared Traditional

K150288 - PDO Absorbable Punctum Plug

K150288 · Riverpoint Medical · Ophthalmic device
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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

Submission Details

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
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 110d · This submission: 204d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZU Plug, Punctum
Device Class -

Regulatory Peers - LZU Plug, Punctum

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