FDA product code · Cardiovascular

Device. Laser Peripheral Angioplasty

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

LWXClass IIIPMA required1 decision since 19870 recalls

1 FDA decision since 1987. 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, cardiovascular panel

Twenty years of LWX 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 · LWX

FDA has decided no LWX device since 2007.

Median 510(k) review, days · LWX

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

Recalls per year · LWX

No recall names LWX since 2007.

Adverse event reports per year · LWX

No MAUDE report names LWX 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 — LWX by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in LWX? 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

Device. Laser Peripheral Angioplasty

What has FDA decided in LWX lately?