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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 K053628
Device Name LIGHTSHEER DUET LASER SYSTEM
Applicant
LUMENIS, INC.
2400 CONDENSA ST.
SANTA CLARA,  CA  95051 -0901
Applicant Contact Connie Hoy
Correspondent
LUMENIS, INC.
2400 CONDENSA ST.
SANTA CLARA,  CA  95051 -0901
Correspondent Contact Connie Hoy
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/29/2005
Decision Date 04/07/2006
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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