Data / Medical devices / United States / Luminopia Inc
Luminopia Inc: FDA-registered device maker in Cambridge, MA, United States, 1 510(k) clearance
Luminopia Inc is registered with the FDA (registration 3023855046) in Cambridge, MA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 20, 2021. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3023855046
- Address
- 955 Massachusetts Ave #335, Cambridge, MA, United States, 02139
- Owner or operator
- Luminopia Inc (10085892)
- Roles
- Manufacturer
- First device listed
- August 31, 2022
- Registered through
- 2027
- Brand names listed
- Luminopia, Luminopia One
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Digital Therapy Device For Amblyopia | QQU | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 20, 2021 | DEN210005 | Luminopia One | QQU | Unknown | Luminopia, Inc. | accessdata.fda.gov |
Updated October 20, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.