Iridex TruFocus LIO Premiere

Powered Laser Surgical Instrument

Iridex Corporation

The following data is part of a premarket notification filed by Iridex Corporation with the FDA for Iridex Trufocus Lio Premiere.

Pre-market Notification Details

Device IDK170718
510k NumberK170718
Device Name:Iridex TruFocus LIO Premiere
ClassificationPowered Laser Surgical Instrument
Applicant Iridex Corporation 1212 Terra Bella Avenue Mountain View,  CA  94043 -1824
ContactGloria Dy
CorrespondentGloria Dy
Iridex Corporation 1212 Terra Bella Avenue Mountain View,  CA  94043 -1824
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-03-09
Decision Date2017-05-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00813125015695 K170718 000
00813125015688 K170718 000
00813125015671 K170718 000
00813125015664 K170718 000
00813125015657 K170718 000

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