FAMILI OF IRIDEX IQ LASER SYSTEMS

Powered Laser Surgical Instrument

IRIDEX CORP.

The following data is part of a premarket notification filed by Iridex Corp. with the FDA for Famili Of Iridex Iq Laser Systems.

Pre-market Notification Details

Device IDK071687
510k NumberK071687
Device Name:FAMILI OF IRIDEX IQ LASER SYSTEMS
ClassificationPowered Laser Surgical Instrument
Applicant IRIDEX CORP. 1212 TERRA BELLA AVE. Mountain View,  CA  94043
ContactDavid Buzawa
CorrespondentDavid Buzawa
IRIDEX CORP. 1212 TERRA BELLA AVE. Mountain View,  CA  94043
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-06-18
Decision Date2008-08-07
Summary:summary

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