IRIDEX Cyclo G6 Laser System, G-Probe Illuminate

Powered Laser Surgical Instrument

IRIDEX CORPORATION

The following data is part of a premarket notification filed by Iridex Corporation with the FDA for Iridex Cyclo G6 Laser System, G-probe Illuminate.

Pre-market Notification Details

Device IDK162416
510k NumberK162416
Device Name:IRIDEX Cyclo G6 Laser System, G-Probe Illuminate
ClassificationPowered Laser Surgical Instrument
Applicant IRIDEX CORPORATION 1212 TERRA BELLA AVENUE Mountain View,  CA  94043
ContactKathy Maynor
CorrespondentKathy Maynor
IRIDEX CORPORATION 1212 TERRA BELLA AVENUE Mountain View,  CA  94043
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-08-30
Decision Date2016-09-29
Summary:summary

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