FDA applicant
Foreo, Inc.
FDA records 11 decisions for Foreo, Inc. (Las Vegas, NV) from 2016 to 2026: 11 510(k) clearances. Most are in product codes OHS (Light Based Over The Counter Wrinkle Reduction) and NFO (Stimulator, Transcutaneous Electrical…). Since 2016 its 510(k)s took a median of 106 days from receipt to decision, against 97 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Foreo, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
5in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2016.
Planning a device like Foreo, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report