FDA applicant

Lumen S.R.L.

Via Col Di Lana, IT1 decision1994–19940 recalls

FDA records 1 decision for Lumen S.R.L. (Via Col Di Lana, IT) in 1994: 1 510(k) clearance. All are in product code HQY (Sunglasses (Non-Prescription Including…). 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 Lumen S.R.L.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Lumen S.R.L. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Lumen S.R.L.’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 “Lumen”

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

Lumen Biomedical, Inc. 5 Lumen Development and Manufacturing, Inc. 1

Lumen S.R.L.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Lumen”