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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 K974381
Device Name CANDELA GENTLELASE GL DERMATOLOGICAL LASER
Original Applicant
CANDELA CORP.
530 boston post rd.
wayland,  MA  01778
Original Contact jan caplan
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/20/1997
Decision Date 02/10/1998
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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