FDA product code · Ophthalmic

Exophthalmometer

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

HLSClass I21 CFR 886.1270510(k) exempt1 decision since 19770 recalls

FDA lists HLS 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. 1 FDA decision since 1977. 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 HLS 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 · HLS

FDA has decided no HLS device since 2007.

Median 510(k) review, days · HLS

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

Recalls per year · HLS

No recall names HLS since 2007.

Adverse event reports per year · HLS

2in 2025

2007high 2 (2025) · low 0 (2007)2025

MAUDE reports naming product code HLS, 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	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	2
2026	—	—

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

Planning a device in HLS? 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

Exophthalmometer

What has FDA decided in HLS lately?