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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 K022060
Device Name LUMENIS ULTRAPULSE ENCORE CARBON DIOXIDE SURGICAL LASERS AND DELIVERY DEVICE ACCESSORIES
Applicant
LUMENIS, INC.
2400 CONDENSA ST.
SANTA CLARA,  CA  95051 -0901
Applicant Contact ANNE WORDEN
Correspondent
LUMENIS, INC.
2400 CONDENSA ST.
SANTA CLARA,  CA  95051 -0901
Correspondent Contact ANNE WORDEN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/25/2002
Decision Date 10/30/2002
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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