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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 K002421
Device Name CANDELA MID IR DIODE LASER SYSTEM
Applicant
Candela Corp.
530 Boston Post Rd.
Wayland,  MA  01778
Applicant Contact JOAN CLIFFORD
Correspondent
Candela Corp.
530 Boston Post Rd.
Wayland,  MA  01778
Correspondent Contact JOAN CLIFFORD
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/08/2000
Decision Date 11/03/2000
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
Predetermined Change
Control Plan Authorized		 No
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