FDA applicant

Hansen Ophthalmic Development Lab

Mchenry, IL1 decision1984–19840 recalls

FDA records 1 decision for Hansen Ophthalmic Development Lab (Mchenry, IL) in 1984: 1 510(k) clearance. All are in product code HNL (Probe, Lachrymal). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Hansen Ophthalmic Development Lab’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hansen Ophthalmic Development Lab since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Hansen Ophthalmic Development Lab’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Hansen”

FDA records each applicant name separately; these may or may not be the same firm.

Hansen Medical, Inc. 17

Hansen Ophthalmic Development Lab

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Hansen”