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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 K903288
Device Name IRIS OCULIGHT SL DIODE LASER PHOTOCOAG/MODIFIED
Applicant
Iriderm Div.
340 Pioneer Way
Mountain View,  CA  94041
Applicant Contact A BPITACPFF
Correspondent
Iriderm Div.
340 Pioneer Way
Mountain View,  CA  94041
Correspondent Contact A BPITACPFF
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/28/1990
Decision Date 09/24/1990
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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