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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 K030033
Device Name LUMENIS FAMILY OF DISPOSABLE CONTACT TIP DELIVERY DEVICES
Applicant
LUMENIS, LTD.
2400 CONDENSA ST.
SANTA CLARA,  CA  95051
Applicant Contact ANNE WORDEN
Correspondent
LUMENIS, LTD.
2400 CONDENSA ST.
SANTA CLARA,  CA  95051
Correspondent Contact ANNE WORDEN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/03/2003
Decision Date 07/21/2003
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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