# K221659: Luminopia One

- Pathway: 510(k) (Traditional)
- Applicant: Luminopia, Inc.
- Decided: Nov 4, 2022 after 149 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
Longest line of descent: 1 generation back to DEN210005 (2021). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN210005: Luminopia One, Luminopia, Inc. (2021) Summary page 4.

## Most influential descendants
- K233720: Luminopia (2024), 1 descendant of its own
- K243819: Luminopia (2025), 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/K221659
Methodology: https://510kreport.com/methodology