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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 K024371
Device Name CANDELA GENTLE LASE FAMILY OF LASER SYSTEM
Applicant
CANDELA CORP.
530 BOSTON POST RD.
WAYLAND,  MA  01778
Applicant Contact WILLIAM H MCGRAIL
Correspondent
CANDELA CORP.
530 BOSTON POST RD.
WAYLAND,  MA  01778
Correspondent Contact WILLIAM H MCGRAIL
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/31/2002
Decision Date 03/31/2003
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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