FDA product code · Ophthalmic

Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

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

LOIClass IIIPMA required10 decisions since 19840 recalls

10 FDA decisions since 1984. No recall names this code. The most-cited predicate is P840012, named by 1 later device.

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 LOI 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 · LOI

FDA has decided no LOI device since 2007.

Median 510(k) review, days · LOI

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

Recalls per year · LOI

No recall names LOI since 2007.

Adverse event reports per year · LOI

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

Planning a device in LOI? 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

Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

Which predicates do LOI devices cite most?

What has FDA decided in LOI lately?