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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name laser, ophthalmic
510(k) Number K122202
Device Name ELLEX 2RT
Original Applicant
Ellex Medical Pty. Ltd.
82 gilbert st.
adelaide, south australia,  AU 5000
Original Contact kevin howard
Regulation Number886.4390
Classification Product Code
Date Received07/25/2012
Decision Date 07/01/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No