510(k) Report

FDA product code · General and plastic surgery

System, Microwave, Hair Removal

MWYClass II21 CFR 878.4400510(k) required2 decisions since 19990 recalls

2 FDA decisions since 1999. No recall names this code.

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, general and plastic surgery panel

Twenty years of MWY 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 · MWY

FDA has decided no MWY device since 2007.

Median 510(k) review, days · MWY

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

Recalls per year · MWY

No recall names MWY since 2007.

Adverse event reports per year · MWY

1in 2020

2016: 12017: 12018: 12019: 12020: 1
2007high 1 (2016) · low 0 (2007)2025

MAUDE reports naming product code MWY, not matched to any one device; reports are not rates.

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—01
20170—01
20180—01
20190—01
20200—01
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — MWY by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MWY? 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

Related product codes

Other codes under 21 CFR 878.4400.