FDA product code QQU: Digital Therapy Device For Amblyopia
QQU is the FDA product code for digital therapy device for amblyopia. It is a Class II device, regulated under 21 CFR 886.5500 and reviewed by the Ophthalmic panel. FDA has cleared 4 510(k) submissions under QQU, 4 in the last five years, from 2 different applicants. The average 510(k) review took 167 days (median 144); 190 days on average over the last three years. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Digital Therapy Device For Amblyopia |
| Device class | Class II |
| Regulation | 21 CFR 886.5500 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
510(k) clearances per year for QQU
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 2 | 144 |
| 2024 | 1 | 261 |
| 2025 | 1 | 118 |
Compare with all 510(k) review times · Search every QQU clearance
Top QQU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Luminopia, Inc. | 3 | 2025-04-09 |
| Novasight , Ltd. | 1 | 2022-09-29 |
Most recent QQU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243819 | Luminopia, Inc. | Luminopia | 2025-04-09 | 118 |
| K233720 | Luminopia, Inc. | Luminopia | 2024-08-08 | 261 |
| K221659 | Luminopia, Inc. | Luminopia One | 2022-11-04 | 149 |
| K221375 | Novasight , Ltd. | CureSight-CS100 | 2022-09-29 | 140 |
Recalls for QQU devices
openFDA lists no recalls for product code QQU.
Frequently asked questions
What is FDA product code QQU?
QQU is the FDA product code for digital therapy device for amblyopia. It is a Class II device, regulated under 21 CFR 886.5500 and reviewed by the Ophthalmic panel.
What device class is QQU?
Class II, regulation 21 CFR 886.5500. Typical premarket route: 510(k).
How long does a 510(k) take for product code QQU?
Across 4 cleared submissions the average was 167 days from receipt to decision (median 144).
Which companies have the most QQU clearances?
Luminopia, Inc. (3); Novasight , Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QQU
- Run a recall and safety report across every QQU manufacturer
- Watch product code QQU for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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