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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 K981351
Device Name CANDELA GENTLELASE GL DERMATOLOGICAL LASER
Original Applicant
CANDELA CORP.
530 boston post rd.
wayland,  MA  01778
Original Contact jay caplan
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/14/1998
Decision Date 07/13/1998
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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