Luminopia

Luminopia is a software-only digital therapeutic application designed to improve visual acuity in children aged 4 to <13 years with amblyopia associated with anisometropia and/or mild strabismus. The software runs on commercially available head-mounted displays (HMDs) and works by applying contrast reduction and dichoptic masks to video content to break interocular suppression and encourage use of the amblyopic eye. It is prescribed by eye-care professionals and used at home as an adjunct to corrective glasses.

The subject device is identical to the predicate in technological characteristics: both are Software as a Medical Device (SaMD) consisting of two software components (Mobile Application and Backend Service Layer), both use the same therapeutic mechanism (contrast reduction plus dichoptic masks applied to video content), both operate on off-the-shelf HMDs, and both list the same compatible HMDs (DPVR P1 Pro 4K and Pico G2 4K). There are no changes to device design, materials, energy source, or hardware platform.

Not stated in this summary.

The subject device demonstrates substantial equivalence because it is technologically identical to the predicate device K233720 with no modifications to the software, therapeutic algorithms, or operational platform. The only change is a label expansion extending the age indication from 4–7 years to 4–<13 years. This label expansion is supported by real-world registry data showing 290 patients aged 4–<13 achieved a mean visual acuity improvement of 1.1 lines (95% CI: 0.92–1.3), with the 8–12 age subgroup (N=104) showing similar improvement of 0.95 lines (95% CI: 0.66–1.3). The adverse event profile in older children (9 events, 3% of 290 patients) remained consistent with safety data from the predicate's prior clinical trial (DEN210005), establishing that expanding use to older children does not introduce new risks while maintaining the established benefit-risk profile.