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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser For Gastro-Urology Use
510(k) Number K901723
Device Name MDL-2000 LASERTRIPTER
Applicant
Candela Laser Corp.
530 Boston Post Rd.
Wayland,  MA  01778
Applicant Contact GEORGE CHO
Correspondent
Candela Laser Corp.
530 Boston Post Rd.
Wayland,  MA  01778
Correspondent Contact GEORGE CHO
Regulation Number878.4810
Classification Product Code
LNK  
Date Received04/16/1990
Decision Date 07/13/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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