Certified eye care apps and devices
17 eye care apps and devices, each checked against the FDA register, EUDAMED and the German DiGA directory. Last checked 18 October 2026.
Eye care has some of the most mature AI in medicine, with autonomous screening for diabetic retinopathy, and new digital treatments for lazy eye in children. There are also home monitoring tools for macular degeneration and remote vision tests.
Below you find every eye care tool we track, grouped by what we could verify in the official registers.
In the US: FDA verified
Authorised by the FDA (510(k), De Novo or PMA), newest decisions first.
- Fundus On Phone
- Luminopia One
- ForeseeHome
- EyeArt® AI Eye Screening
iExaminer Pro - CureSight
- LumineticsCore
- LuxIA
- Visibly Vision Test
In the EU: CE class IIa or higher
Found in EUDAMED as class IIa or higher. We show whether a notified body certificate is visible there.
CE class I (self-declared)
Self-declared by the maker, without review by a notified body. We list these apart.
Watchlist
These products are presented as certified, by their maker or in earlier directories, but we found no matching record in the official register, or they are no longer supported by their maker. Some are registered and listed with the FDA as exempt devices, which is legal but is not a clearance.
The trap to avoid
Online vision tests are the most common uncertain claim in this area: four are on our watchlist. A cleared remote test checks specific things for specific users. It does not replace a full eye examination.
Questions
Is there an FDA-authorised treatment for lazy eye?
Yes. Luminopia, a headset based therapy, was authorised through the De Novo route, with a 2025 decision in our directory. CureSight holds a 510(k).
Can AI screen for diabetic retinopathy without a doctor?
For screening, yes, within the cleared indication. LumineticsCore (formerly IDx-DR) was the first autonomous AI diagnostic system authorised by the FDA, and EyeArt also holds clearances. Indications and the role of the clinician differ per system, so check the exact indication. A positive result leads to a referral.
Can an online test replace an eye exam?
No. The Visibly Vision Test holds a 510(k) for a limited remote check. A full eye examination looks at much more than visual acuity.
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