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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Ophthalmic
510(k) Number K031665
Device Name IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS
Applicant
IRIDEX CORP.
1212 TERRA BELLA AVE.
MOUNTAIN VIEW,  CA  94043
Applicant Contact JOHN JOSSY
Correspondent
IRIDEX CORP.
1212 TERRA BELLA AVE.
MOUNTAIN VIEW,  CA  94043
Correspondent Contact JOHN JOSSY
Regulation Number886.4390
Classification Product Code
HQF  
Date Received05/29/2003
Decision Date 08/27/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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