Cleared Traditional

K150288 - PDO Absorbable Punctum Plug (FDA 510(k) Clearance)

Aug 2015
Decision
204d
Days
Risk

K150288 is an FDA 510(k) clearance for the PDO Absorbable Punctum Plug. This device is classified as a Plug, Punctum.

Submitted by Riverpoint Medical (Portland, US). The FDA issued a Cleared decision on August 28, 2015, 204 days after receiving the submission on February 5, 2015.

This device falls under the Ophthalmic FDA review panel.

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

Device Classification

Product Code LZU — Plug, Punctum
Device Class