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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 K063072
Device Name CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS: 532 AND 1064 ND:YAG HANDPIECE ACCESSORIES
Original Applicant
CANDELA CORP.
530 boston post road
wayland,  MA  01778
Original Contact jeffery roberts
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/06/2006
Decision Date 12/20/2006
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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