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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 K855197
Device Name FIBERLASE 100 ND: YAG MEDICAL LASER SYSTEM
Applicant
Laser Media
77 Arkay Dr.
Hauppauge,  NY  11788
Applicant Contact ROBERT KAPLAN
Correspondent
Laser Media
77 Arkay Dr.
Hauppauge,  NY  11788
Correspondent Contact ROBERT KAPLAN
Regulation Number878.4810
Classification Product Code
LNK  
Date Received12/26/1985
Decision Date 01/21/1986
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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