Luminopia One

Digital Therapy Device For Amblyopia

Luminopia, Inc.

The following data is part of a premarket notification filed by Luminopia, Inc. with the FDA for Luminopia One.

Pre-market Notification Details

Device IDK221659
510k NumberK221659
Device Name:Luminopia One
ClassificationDigital Therapy Device For Amblyopia
Applicant Luminopia, Inc. 955 Massachusetts Ave #335 Cambridge,  MA  02139
ContactScott Xiao
CorrespondentScott Xiao
Luminopia, Inc. 955 Massachusetts Ave #335 Cambridge,  MA  02139
Product CodeQQU  
CFR Regulation Number886.5500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-08
Decision Date2022-11-04

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