510(k) Report

FDA applicant

Lace Electronica S.R.L.

Clearwater, FL1 decision2005–20050 recalls

FDA records 1 decision for Lace Electronica S.R.L. (Clearwater, FL) in 2005: 1 510(k) clearance. All are in product code GWE (Stimulator, Photic, Evoked Response). 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, neurology panel, where it files most

How often FDA has decided Lace Electronica S.R.L.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Lace Electronica S.R.L. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • GWEStimulator, Photic, Evoked Response1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K043367Glaid Ocular Electrophysiology DeviceLace Electronica S.R.L. · 20051cites it

What has FDA decided for it lately?

  • K043367Glaid Ocular Electrophysiology DeviceLace Electronica S.R.L. · 2005

The one decision as Lace Electronica S.R.L. →