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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 K140732
Device Name CANDELA GENTLELASE FAMILY OF LASER SYSTEMS
Applicant
CANDELA CORP.
530 BOSTON POST ROAD
WAYLAND,  MA  01778
Applicant Contact SAM WADE
Correspondent
CANDELA CORP.
530 BOSTON POST ROAD
WAYLAND,  MA  01778
Correspondent Contact SAM WADE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/24/2014
Decision Date 11/07/2014
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
Predetermined Change
Control Plan Authorized		 No
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