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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 K833499
Device Name FIBERLAS 100 MEDICAL SYSTEM
Applicant
Fiberlase U.S.A.
7600 Ridge Blvd Brooklun,  NY 
Correspondent
Fiberlase U.S.A.
7600 Ridge Blvd Brooklun,  NY 
Regulation Number878.4810
Classification Product Code
LNK  
Date Received10/05/1983
Decision Date 04/02/1984
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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