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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 K030147
Device Name LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS
Applicant
LUMENIS, LTD.
2400 CONDENSA ST.
SANTA CLARA,  CA  95051
Applicant Contact ANNA WORDEN
Correspondent
Boston Scientific
100 Boston Scientific Way
Marlborough,  MD  01752
Correspondent Contact Donn M Gardner
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/15/2003
Decision Date 04/15/2003
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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