510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QQUClass II

Digital Therapy Device For Amblyopia

21 CFR 886.5500 / Ophthalmic
FDA source (opens on fda.gov)

QQU is the FDA product code for Digital Therapy Device For Amblyopia, a class II device type, regulated under 21 CFR 886.5500. FDA's definition for this code reads: "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". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QQU
Device name
Digital Therapy Device For Amblyopia
FDA definition
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.
Regulation
21 CFR 886.5500
Device class
Class II
Review panel
Ophthalmic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
5
Ingested recalls
0

Clearances, product code QQU

By decision year
5 clearances under product code QQU with a decision year between 2021 and 2025, 2022 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code QQU by decision year
YearClearances
20211
20222
20241
20251

Applicants with the most clearances

Product code QQU
Applicants holding the most 510(k) clearances under product code QQU
ApplicantClearances
Luminopia Inc4
Novasight1

Companies listing this code with FDA

Companies whose registered establishments list this code