# DEN210005: Luminopia One

- Pathway: De Novo (Direct)
- Applicant: Luminopia, Inc.
- Decided: Oct 20, 2021 after 233 days
- Product code: QQU (Digital Therapy Device For Amblyopia)
- Device class: 2
- Regulation: 21 CFR 886.5500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K221659: Luminopia One (2022), 2 descendants of its own
- K233720: Luminopia (2024), 1 descendant of its own
- K243819: Luminopia (2025), 0 descendants of its own
- K221375: CureSight-CS100 (2022), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/DEN210005
Methodology: https://510kreport.com/methodology