Cleared Traditional

SOFT PLUG Extended Duration 180 Tapered Canalicular Plug

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

About This 510(k) Submission

K213988 is an FDA 510(k) clearance for the SOFT PLUG Extended Duration 180 Tapered Canalicular Plug, a Plug, Punctum, submitted by Oasis Medical, Inc. (Glendora, US). The FDA issued a Cleared decision on June 3, 2022, 165 days after receiving the submission on December 20, 2021. This device falls under the Ophthalmic review panel.

Submission Details

510(k) Number K213988 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code LZU — Plug, Punctum
Device Class —