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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 K133283
Device Name CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS
Original Applicant
CANDELA CORP.
530 boston post road
wayland,  MA  01778
Original Contact sam wade
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/29/2013
Decision Date 12/26/2013
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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