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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 K994260
Device Name CANDELA GENTLELASE GL DERMATOLOGICAL LASER
Applicant
CANDELA CORP.
530 BOSTON POST RD.
WAYLAND,  MA  01778
Applicant Contact JAY CAPLAN
Correspondent
CANDELA CORP.
530 BOSTON POST RD.
WAYLAND,  MA  01778
Correspondent Contact JAY CAPLAN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/17/1999
Decision Date 05/26/2000
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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