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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K894841
Device Name IRIS OCULIGHT(TM) SL
Applicant
Iriderm Div.
Post Office Box 4276
Mountain View,  CA  94040
Applicant Contact A BOUTACOFF
Correspondent
Iriderm Div.
Post Office Box 4276
Mountain View,  CA  94040
Correspondent Contact A BOUTACOFF
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/31/1989
Decision Date 10/05/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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