QQU · Class II · 21 CFR 886.5500

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..

5
Total
4
Cleared
180d
Avg days
2021
Since
Declining activity - 1 submissions in the last 2 years vs 3 in the prior period
Review times improving: avg 118d recently vs 196d historically

FDA 510(k) Cleared Digital Therapy Device For Amblyopia Devices (Product Code QQU)

5 devices
1–5 of 5
Cleared Apr 09, 2025
Luminopia
K243819
Luminopia, Inc.
Ophthalmic · 118d
Cleared Aug 08, 2024
Luminopia
K233720
Luminopia, Inc.
Ophthalmic · 261d
Cleared Nov 04, 2022
Luminopia One
K221659
Luminopia, Inc.
Ophthalmic · 149d
Cleared Sep 29, 2022
CureSight-CS100
K221375
Novasight , Ltd.
Ophthalmic · 140d
Not Cleared Oct 20, 2021
Luminopia One
DEN210005
Luminopia, Inc.
Ophthalmic · 233d

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 declined in recent years - 1 submissions in the last 24 months compared to 3 in the prior period.

FDA 510(k) Review Time - QQU Product Code

Recent submissions under QQU have taken an average of 118 days to reach a decision - down from 196 days historically, suggesting improved FDA processing for this classification.

QQU devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →