Cleared Traditional

ILWAIT TIMER OCULOPRESSOR

K112952 · Oryx Medical Pty, Ltd. · Ophthalmic
May 2012
Decision
218d
Days
Class 2
Risk

About This 510(k) Submission

K112952 is an FDA 510(k) clearance for the ILWAIT TIMER OCULOPRESSOR, a Applicator, Ocular Pressure (Class II — Special Controls, product code LCC), submitted by Oryx Medical Pty, Ltd. (Maylands, AT). The FDA issued a Cleared decision on May 10, 2012, 218 days after receiving the submission on October 5, 2011. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4610.

Submission Details

510(k) Number K112952 FDA.gov
FDA Decision Cleared SESE
Date Received October 05, 2011
Decision Date May 10, 2012
Days to Decision 218 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code LCC — Applicator, Ocular Pressure
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4610