Medical Device Manufacturer · US , Cambridge , MA

Luminopia, Inc. - FDA 510(k) Cleared Devices

4 submissions · 3 cleared · Since 2021

4

Total

3

Cleared

1

Denied

FDA 510(k) Regulatory Record - Luminopia, Inc. Ophthalmic ✕

4 devices

1-4 of 4

Cleared CT Apr 09, 2025

Ophthalmic · 118d

Cleared Aug 08, 2024

Ophthalmic · 261d

Cleared Nov 04, 2022

Ophthalmic · 149d

Not Cleared Oct 20, 2021

DEN210005 · QQU

Ophthalmic · 233d

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: May 02, 2026