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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 K050796
Device Name AURORA DS, DS APPLICATOR
Applicant
SYNERON MEDICAL LTD.
P.O. BOX 550
INDUSTRIAL ZONE
YOKNEAM ILLIT,  IL 20692
Applicant Contact AMIR WALDMAN
Correspondent
SYNERON MEDICAL LTD.
P.O. BOX 550
INDUSTRIAL ZONE
YOKNEAM ILLIT,  IL 20692
Correspondent Contact AMIR WALDMAN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/29/2005
Decision Date 04/12/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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