Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm And 577 Nm Models)

Laser, Ophthalmic

Iridex Corporation

The following data is part of a premarket notification filed by Iridex Corporation with the FDA for Iridex Pascal® 532, Iridex Pascal® 577, Iridex Pascal® (532nm And 577 Nm Models).

Pre-market Notification Details

Device IDK223132
510k NumberK223132
Device Name:Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm And 577 Nm Models)
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 Received2022-10-03
Decision Date2022-11-09

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