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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 K001093
Device Name CANDELA SPTL-1B PULSED DYE LASER
Applicant
CANDELA CORP.
530 BOSTON POST RD.
WAYLAND,  MA  01778
Applicant Contact JOAN M CLIFFORD
Correspondent
CANDELA CORP.
530 BOSTON POST RD.
WAYLAND,  MA  01778
Correspondent Contact JOAN M CLIFFORD
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/04/2000
Decision Date 09/19/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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