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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 K083733
Device Name LUME 2 SYSTEM, MODEL GA0005000
Applicant
Lumenis, Ltd.
3959 W. 1820 S.
Salt Lake City,  UT  84104
Applicant Contact FRANCES HARRISON
Correspondent
Lumenis, Ltd.
3959 W. 1820 S.
Salt Lake City,  UT  84104
Correspondent Contact FRANCES HARRISON
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/16/2008
Decision Date 05/04/2009
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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