Luminopia One

Digital Therapy Device For Amblyopia

Luminopia, Inc.

The following data is part of a De Novo classification by Luminopia, Inc. with the FDA for Luminopia One.

Pre-market Notification Details

DeNovo IDDEN210005
Device Name:Luminopia One
ClassificationDigital Therapy Device For Amblyopia
Applicant Luminopia, Inc. 955 Massachusetts Ave #335 Cambridge,  MA  02139
ContactScott Xiao
Product CodeQQU  
CFR Regulation Number886.5500 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardOphthalmic
Classification AdvisoryOphthalmic
TypeDirect
Date Received2021-03-01
Decision Date2021-10-20
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00860007887123 DEN210005 000
00860007887116 DEN210005 000
00860007887109 DEN210005 000

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