FDA product code · Ophthalmic

Medical Computers And Software For Ophthalmic Use

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

LQBClass IIIPathway set case by case2 decisions since 19860 recalls

2 FDA decisions since 1986. 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 LQB 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 · LQB

FDA has decided no LQB device since 2007.

Median 510(k) review, days · LQB

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

Recalls per year · LQB

No recall names LQB since 2007.

Adverse event reports per year · LQB

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

Planning a device in LQB? 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

Medical Computers And Software For Ophthalmic Use

What has FDA decided in LQB lately?