# Luminopia, Inc.

- Location (FDA's records): Cambridge, MA
- FDA decisions: 4 (2021–2025): 3 510(k) clearances and 1 De Novo grant
- Product codes: QQU (4)
- Predicates its devices cite: 3 (3 its own); citations of its devices by later devices: 4 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Novasight, Ltd.: 1 (https://510kreport.com/company/novasight)

## Its most-cited devices
- DEN210005: Luminopia One (2021), cited by 2
- K221659: Luminopia One (2022), cited by 1
- K233720: Luminopia (2024), cited by 1

## Recent decisions
- K243819: Luminopia (Apr 9, 2025)
- K233720: Luminopia (Aug 8, 2024)
- K221659: Luminopia One (Nov 4, 2022)
- DEN210005: Luminopia One (Oct 20, 2021)

Source page: https://510kreport.com/company/luminopia