510(k) Report

FDA applicant

Luminopia, Inc.

Cambridge, MA4 decisions2021–20250 recalls

FDA records 4 decisions for Luminopia, Inc. (Cambridge, MA) from 2021 to 2025: 3 510(k) clearances and 1 De Novo grant. All are in product code QQU (Digital Therapy Device For Amblyopia). Its devices cite 3 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Luminopia, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2021: 12022: 12024: 12025: 1
2021high 1 (2021) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Luminopia, Inc. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Luminopia, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • QQUDigital Therapy Device For Amblyopia4decisions

Who builds on its devices?

Later devices cite its devices 4 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • DEN210005Luminopia OneLuminopia, Inc. · 20212cite it
  • K221659Luminopia OneLuminopia, Inc. · 20221cites it
  • K233720LuminopiaLuminopia, Inc. · 20241cites it

What has FDA decided for it lately?

  • K243819LuminopiaLuminopia, Inc. · 2025
  • K233720LuminopiaLuminopia, Inc. · 2024
  • K221659Luminopia OneLuminopia, Inc. · 2022
  • DEN210005Luminopia OneLuminopia, Inc. · 2021

All 4 as Luminopia, Inc. →