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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 K051359
Device Name CANDELA FAMILY OF PULSED DYE LASER SYSTEMS: PIGMENTED LESION HANDPIECE ACCESSORY
Applicant
CANDELA CORP.
530 BOSTON POST RD.
WAYLAND,  MA  01778
Applicant Contact LORRAINE CALZETTA PATROVIC
Correspondent
CANDELA CORP.
530 BOSTON POST RD.
WAYLAND,  MA  01778
Correspondent Contact LORRAINE CALZETTA PATROVIC
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/24/2005
Decision Date 07/13/2005
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
Recalls CDRH Recalls
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