FDA applicant
EMA Aesthetics, Ltd.
FDA records 2 decisions for EMA Aesthetics, Ltd. (Dublin 2, IE) in 2025: 2 510(k) clearances. Most are in product codes NFO (Stimulator, Transcutaneous Electrical…) and PBX (Massager, Vacuum, Radio Frequency Induced Heat). 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 EMA Aesthetics, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2025high 2 (2025)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2025.
Planning a device like EMA Aesthetics, Ltd.’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