510(k) Report

FDA product code · Neurology

Stimulator, Electrical, Transcutaneous, With Limited Output, For Aesthetic Purposes

NYXClass II21 CFR 882.5890510(k) required0 decisions0 recalls

0 FDA decisions. No recall names this code.

Electrical stimulation for aesthetic purposes

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, neurology panel

Twenty years of NYX at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · NYX

FDA has decided no NYX device since 2007.

Median 510(k) review, days · NYX

Too few NYX 510(k)s in any year since 2007 to give a median.

Recalls per year · NYX

No recall names NYX since 2007.

Adverse event reports per year · NYX

No MAUDE report names NYX since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — NYX by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NYX? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

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