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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 K140122
Device Name CANDELA GENTLEMAX FAMILY OF LASER SYSTEM
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  
Subsequent Product Code
PDZ  
Date Received01/16/2014
Decision Date 05/09/2014
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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