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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 K073572
Device Name MATRIX RF APPLICATOR
Applicant
Syneron Medical, Ltd.
P.O. Box 550
Industrial Zone
Yokneam Illit,  IL 20692
Applicant Contact YONI IGER
Correspondent
Syneron Medical, Ltd.
P.O. Box 550
Industrial Zone
Yokneam Illit,  IL 20692
Correspondent Contact YONI IGER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/19/2007
Decision Date 09/17/2008
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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