De Novo · Granted
GrantedLuminopia One
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Luminopia, Inc. · QQU Digital Therapy Device For Amblyopia
Granted on Oct 20, 2021 as a new device type through De Novo after a 233-day review. 4 later devices descend from it.
- Decided
- Oct 20, 2021
- Review
- 233 days
- Class
- Class II
- Product code
- QQU
- Recalls
- None
4 later devices descend from it, 2 citing it directly.
- This deviceDEN210005 Luminopia OneLuminopia, Inc. · 2021
- Descendant · cites it directly · 2 of its ownK221659 Luminopia OneLuminopia, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK233720 LuminopiaLuminopia, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK243819 LuminopiaLuminopia, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK221375 CureSight-CS100Novasight, Ltd. · 2022
Most influential descendants
Showing 4 of 4 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN210005 | Luminopia One | Luminopia, Inc. | 2021 | — |
| +1 | K221659 | Luminopia One | Luminopia, Inc. | 2022 | — |
| +2 | K233720 | Luminopia | Luminopia, Inc. | 2024 | — |
| +3 | K243819 | Luminopia | Luminopia, Inc. | 2025 | — |
| +1 | K221375 | CureSight-CS100 | Novasight, Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QQU? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QQU device
- #1 K233720 Luminopiascore 11.1 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K221659 (Luminopia, Inc., 2022) has gone furthest, with 2 descendants of its own.
How does its category compare?
All QQU devicesQQU Digital Therapy Device For Amblyopia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · QQU
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QQU
Too few QQU 510(k)s in any year since 2007 to give a median.
Recalls per year · QQU
No recall names QQU since 2007.
Adverse event reports per year · QQU
1in 2025
MAUDE reports naming product code QQU, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Luminopia One is a software-only digital therapeutic designed to be used with commercially available Head-Mounted Displays (HMDs) which are compatible with the software application. Luminopia One is indicated for improvement in visual acuity in amblyopia patients, aged 4-7, associated with anisometropia and/or with mild strabismus, having received treatment instructions (frequency and duration) as prescribed by a trained eye-care professional. Luminopia…
Read the full statement (129 words)
Luminopia One is a software-only digital therapeutic designed to be used with commercially available Head-Mounted Displays (HMDs) which are compatible with the software application. Luminopia One is indicated for improvement in visual acuity in amblyopia patients, aged 4-7, associated with anisometropia and/or with mild strabismus, having received treatment instructions (frequency and duration) as prescribed by a trained eye-care professional. Luminopia One is intended for both previously treated and untreated patients; however, patients with more than 12 months of prior treatment (other than refractive correction) have not been studied. Luminopia One is intended to be used as an adjunct to full-time refractive correction, such as glasses, which should also be worn under the HMD during Luminopia One therapy. Luminopia One is intended for prescription use only, in an at-home environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN210005 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN210005: Luminopia One.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN210005
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026