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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Applicator, Ocular Pressure
510(k) Number K112952
Device Name ILWAIT TIMER OCULOPRESSOR
Applicant
Oryx Medical Pty, Ltd.
Unit 4/43 Caledonian Ave.
Maylands,  AT 6051
Applicant Contact ANNE F JONES
Correspondent
Oryx Medical Pty, Ltd.
Unit 4/43 Caledonian Ave.
Maylands,  AT 6051
Correspondent Contact ANNE F JONES
Regulation Number886.4610
Classification Product Code
LCC  
Date Received10/05/2011
Decision Date 05/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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