Iridex 810 Laser

Laser, Ophthalmic

Iridex Corporation

The following data is part of a premarket notification filed by Iridex Corporation with the FDA for Iridex 810 Laser.

Pre-market Notification Details

Device IDK202760
510k NumberK202760
Device Name:Iridex 810 Laser
ClassificationLaser, Ophthalmic
Applicant Iridex Corporation 1212 Terra Bella Ave. Mountain View,  CA  94043
ContactBill Hyatt
CorrespondentBill Hyatt
Iridex Corporation 1212 Terra Bella Ave. Mountain View,  CA  94043
Product CodeHQF  
CFR Regulation Number886.4390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-21
Decision Date2020-10-21

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.