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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 K062719
Device Name GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIES
Original Applicant
LASERSCOPE
3070 orchard dr.
san jose,  CA  95134 2011
Original Contact paul hardiman
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/12/2006
Decision Date 12/01/2006
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
Recalls CDRH Recalls
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