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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 K050673
Device Name CANDELA FAMILY OF PULSE DYE LASER SYSTEMS
Applicant
Candela Corp.
530 Boston Post Rd.
Wayland,  MA  01886
Applicant Contact LORRAINE CALZETTA PATROVIC
Correspondent
Candela Corp.
530 Boston Post Rd.
Wayland,  MA  01886
Correspondent Contact LORRAINE CALZETTA PATROVIC
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/15/2005
Decision Date 06/13/2005
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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