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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 K130164
FOIA Releasable 510(k) K130164
Device Name FIBERLASE ENDURE CO2 FIBER
Applicant
Lumenis, Ltd.
31 Haavoda St.
Binyamina,  IL 30500
Applicant Contact YORAM LEVY
Correspondent
Lumenis, Ltd.
31 Haavoda St.
Binyamina,  IL 30500
Correspondent Contact YORAM LEVY
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/23/2013
Decision Date 03/24/2013
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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