Cleared Traditional

Soft Plug Extended Duration 180 Canalicular Plug

K162361 · Oasis Medical, Inc. · Ophthalmic
Apr 2017
Decision
237d
Days
—
Risk

About This 510(k) Submission

K162361 is an FDA 510(k) clearance for the Soft Plug Extended Duration 180 Canalicular Plug, a Plug, Punctum, submitted by Oasis Medical, Inc. (Glendora, US). The FDA issued a Cleared decision on April 17, 2017, 237 days after receiving the submission on August 23, 2016. This device falls under the Ophthalmic review panel.

Submission Details

510(k) Number K162361 FDA.gov
FDA Decision Cleared SESE
Date Received August 23, 2016
Decision Date April 17, 2017
Days to Decision 237 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code LZU — Plug, Punctum
Device Class —