510(k) Report

FDA applicant

EMA Aesthetics, Ltd.

Dublin 2, IE2 decisions2025–20250 recalls

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, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided EMA Aesthetics, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2025: 2
2025high 2 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

FIG. 1 — EMA Aesthetics, Ltd. by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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