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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 K081324
Device Name CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASERS
Applicant
CANDELA CORP.
530 BOSTON POST ROAD
WAYLAND,  MA  01778
Applicant Contact LISA LACROIX
Correspondent
CANDELA CORP.
530 BOSTON POST ROAD
WAYLAND,  MA  01778
Correspondent Contact LISA LACROIX
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/12/2008
Decision Date 06/17/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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