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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 K861173
Device Name OPTILASE YAG MODEL 1000 SURG LASER SYSTEM/GASTRO
Applicant
Trimedyne, Inc.
1815 E. Carnegie Ave.
Santa Ana,  CA  92705
Applicant Contact HUSSEIN, PH.D.
Correspondent
Trimedyne, Inc.
1815 E. Carnegie Ave.
Santa Ana,  CA  92705
Correspondent Contact HUSSEIN, PH.D.
Regulation Number878.4810
Classification Product Code
LNK  
Date Received03/28/1986
Decision Date 07/25/1986
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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