Is Prismira FDA approved or cleared?
Yes. Prismira by Lumos Labs, Inc. is named in the FDA register with a 510(k) clearance, latest decision in 2025.
In the EU: no CE listing found in EUDAMED. Not every CE-marked device is registered there yet.
At a glance
| Product | Prismira |
|---|---|
| Maker | Lumos Labs, Inc. |
| Care area | Mental health |
| What it does | Prescription game-based therapy to improve attention function, measured with TOVA, in adults aged 22 to 55 with inattentive or combined-type ADHD |
| FDA | 510(k), latest decision 2025 |
| Verification level | Exact product named in the FDA record (checked 18 October 2026) |
| EU (CE) | No CE listing found |
| Website | lumosity.com |
| Status | FDA verified |
| Last checked | 7 October 2026 |
Need the evidence behind this entry?
Certified Health Apps Pro gives you the FDA reference number, decision date and a direct link to the official record, plus the EU certificate and notified body, for every app. See Pro · Free guide: how to check a health app in two minutes
Certified Health Apps Pro gives you the FDA reference number, decision date and a direct link to the official record, plus the EU certificate and notified body, for every app. See Pro · Free guide: how to check a health app in two minutes
Other apps in Mental health
- CanvasDx
- DaylightRx
- EndeavorRx
- Freespira
- Modius Spero
- Motivista (CT-155)
- Pivot Breathe
- Prism for PTSD