IRIDEX WIRELESS FOOTSWITCH

Laser, Ophthalmic

IRIDEX CORP.

The following data is part of a premarket notification filed by Iridex Corp. with the FDA for Iridex Wireless Footswitch.

Pre-market Notification Details

Device IDK062074
510k NumberK062074
Device Name:IRIDEX WIRELESS FOOTSWITCH
ClassificationLaser, Ophthalmic
Applicant IRIDEX CORP. 1212 TERRA BELLA AVE. Mountain View,  CA  94043
ContactJohn Jossy
CorrespondentJohn Jossy
IRIDEX CORP. 1212 TERRA BELLA AVE. Mountain View,  CA  94043
Product CodeHQF  
CFR Regulation Number886.4390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-07-21
Decision Date2006-11-14
Summary:summary

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