Is Smileyscope FDA approved or cleared?
Yes. Smileyscope by Smileyscope Holding, Inc. is named in the FDA register with a 510(k) clearance, latest decision in 2023.
In the EU: CE class I (self-declared by the maker).
At a glance
| Product | Smileyscope |
|---|---|
| Maker | Smileyscope Holding, Inc. |
| Care area | Pain & neuromodulation |
| What it does | Virtual reality platform for pediatric anxiety and pain management during procedures |
| FDA | 510(k), latest decision 2023 |
| Verification level | Exact product named in the FDA record (checked 18 October 2026) |
| EU (CE) | Class I (self-declared) |
| Website | smileyscope.com |
| Status | FDA verified |
| Last checked | 6 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