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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K021149
Device Name AURORA DS
Applicant
Syneron Medical, Ltd.
Pob 550
Yokneam Elite,  IL 20692
Applicant Contact AMIR WALDMANN
Correspondent
Syneron Medical, Ltd.
Pob 550
Yokneam Elite,  IL 20692
Correspondent Contact AMIR WALDMANN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/10/2002
Decision Date 07/09/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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