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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 K040209
Device Name IRIS MEDICAL IQ 810 PHOTOCOAGULATOR
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  
Subsequent Product Code
GEX  
Date Received01/30/2004
Decision Date 09/20/2004
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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