FDA product code · Ophthalmic

Ultrasound, Cyclodestructive

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

LZRClass II21 CFR 886.5350510(k) required1 decision since 19880 recalls

1 FDA decision since 1988. No recall names this code.

An ultrasound cyclodestructive device uses high intensity focused ultrasound (HIFU) energy to create lesions in the ciliary body and/or trabecular meshwork to reduce intraocular pressure in glaucoma patients.

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 LZR 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 · LZR

FDA has decided no LZR device since 2007.

Median 510(k) review, days · LZR

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

Recalls per year · LZR

No recall names LZR since 2007.

Adverse event reports per year · LZR

2in 2019

2007high 2 (2019) · low 0 (2007)2025

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

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	—	2
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in LZR? 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

Ultrasound, Cyclodestructive

What has FDA decided in LZR lately?