# K233720: Luminopia

- Pathway: 510(k) (Traditional)
- Applicant: Luminopia, Inc.
- Decided: Aug 8, 2024 after 261 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: 2 generations back to DEN210005 (2021). 2 ancestors in all.
1 later device descends 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)
- K221659: Luminopia One, Luminopia, Inc. (2022) Summary page 5.

## Most influential descendants
- K243819: Luminopia (2025), 0 descendants of its own

## Indications for use
Luminopia 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 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 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 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 therapy. Luminopia is intended for prescription use only, in an at-home environment.

Source page: https://510kreport.com/device/K233720
Methodology: https://510kreport.com/methodology