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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 K112715
Device Name CANDELA GENTLEMAX FAMILY OF LASERS
Original Applicant
CANDELA CORP.
530 boston post road
wayland,  MA  01778
Original Contact sam wade
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/19/2011
Decision Date 10/05/2011
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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