# K243819: Luminopia

- Pathway: 510(k) (Traditional)
- Applicant: Luminopia, Inc.
- Decided: Apr 9, 2025 after 118 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: 3 generations back to DEN210005 (2021). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233720: Luminopia, Luminopia, Inc. (2024) Summary page 5.

## 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 to <13, 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. Luminopia is intended to be used as an adjunct to full-time refractive correction, such as glasses, which should also be worn under the HMO during Luminopia therapy. Luminopia is intended for prescription use only, in an at-home environment.

Source page: https://510kreport.com/device/K243819
Methodology: https://510kreport.com/methodology