FDA product code · Ophthalmic

Gauge, Lens, Ophthalmic

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

HLNClass I21 CFR 886.1420510(k) exempt2 decisions since 19800 recalls

FDA lists HLN as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 886.9 applies, such as a new intended use or a different fundamental technology. 2 FDA decisions since 1980. 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 HLN 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 · HLN

FDA has decided no HLN device since 2007.

Median 510(k) review, days · HLN

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

Recalls per year · HLN

No recall names HLN since 2007.

Adverse event reports per year · HLN

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

Planning a device in HLN? 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

Gauge, Lens, Ophthalmic

What has FDA decided in HLN lately?