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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 K030527
Device Name LUMENIS FAMILY OF IPL AND COMBINATION IPL/ND:YAG SYSTEMS
Original Applicant
LUMENIS
2400 condensa st.
santa clara,  CA  95051
Original Contact andrea l ruth
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/19/2003
Decision Date 05/20/2003
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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