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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 K060448
Device Name LUMENIS ONE FAMILY OF SYSTEMS; LUMENIS ONE.
Applicant
LUMENIS LTD.
2400 CONDENSA STREET
SANTA CLARA,  CA  95051
Applicant Contact MARTHA MURARI
Correspondent
LUMENIS LTD.
2400 CONDENSA STREET
SANTA CLARA,  CA  95051
Correspondent Contact MARTHA MURARI
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/21/2006
Decision Date 07/06/2006
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
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