FDA product code · Ophthalmic

Electrosurgical, Radio Frequency, Refractive Correction

Name: FDA decisions, review times, recalls and adverse event reports for product code MWD
Creator: 510(k) Report

MWDClass IIIPMA required1 decision since 20020 recalls

1 FDA decision since 2002. 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, ophthalmic panel

Twenty years of MWD 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 · MWD

FDA has decided no MWD device since 2007.

Median 510(k) review, days · MWD

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

Recalls per year · MWD

No recall names MWD since 2007.

Adverse event reports per year · MWD

No MAUDE report names MWD since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

FIG. 1 — MWD by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MWD? 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

Electrosurgical, Radio Frequency, Refractive Correction

What has FDA decided in MWD lately?