FDA product code · Ophthalmic

System, Identification, Contact Lens

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

LOHClass IIIPMA required1 decision since 19830 recalls

1 FDA decision since 1983. 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 LOH 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 · LOH

FDA has decided no LOH device since 2007.

Median 510(k) review, days · LOH

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

Recalls per year · LOH

No recall names LOH since 2007.

Adverse event reports per year · LOH

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

Planning a device in LOH? 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

System, Identification, Contact Lens

What has FDA decided in LOH lately?