FDA Product Code QQU: Digital Therapy Device For Amblyopia
A Digital Therapy Device For Amblyopia Is A Device That Incorporates Dichoptic Presentations On Visual Displays Through Therapeutic Algorithms To Treat Amblyopia Or To Improve Visual Acuity Of Patients With Amblyopia.
Leading manufacturers include Luminopia, Inc. and Novasight , Ltd..
FDA 510(k) Cleared Digital Therapy Device For Amblyopia Devices (Product Code QQU)
About Product Code QQU - Regulatory Context
510(k) Submission Activity
5 total 510(k) submissions under product code QQU since 2021, with 4 receiving FDA clearance (average review time: 180 days).
Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA Review Time
FDA review times for QQU submissions have been consistent, averaging 190 days recently vs 174 days historically.
QQU devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →