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Is Luminopia One FDA approved or cleared?

Yes. Luminopia One by Luminopia, Inc. is named in the FDA register with a De Novo authorisation, first authorised in 2021, 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	Luminopia One
Maker	Luminopia, Inc.
Care area	Eyes & vision
What it does	Virtual reality therapeutic for amblyopia treatment in children
FDA	De Novo, latest decision 2025
Verification level	Exact product named in the FDA record (checked 18 October 2026)
EU (CE)	No CE listing found
Website	luminopia.com
Status	FDA verified
Last checked	6 October 2026

Certification status can change. Always confirm in the official register before relying on it: the FDA databases, EUDAMED or the BfArM DiGA directory.

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