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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 K852798
Device Name FIBERLASE 100 MEDICAL LASER SYSTEM
Applicant
Laser Media
77 Arkay Dr.
Hauppauge,  NY  11788
Applicant Contact ROBERT A KAPLAN
Correspondent
Laser Media
77 Arkay Dr.
Hauppauge,  NY  11788
Correspondent Contact ROBERT A KAPLAN
Regulation Number878.4810
Classification Product Code
LNK  
Date Received07/01/1985
Decision Date 07/29/1985
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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