510(k) Report

FDA applicant

Mattioli Engineering Corp.

Florence, IT5 decisions1994–20100 recalls

FDA records 5 decisions for Mattioli Engineering Corp. (Florence, IT) from 1994 to 2010: 5 510(k) clearances. Most are in product codes EGJ (Device, Iontophoresis, Other Uses) and GFD (Dermatome). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Mattioli Engineering, Srl”.

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

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Mattioli Engineering Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Which product codes does it file in?

  • EGJDevice, Iontophoresis, Other Uses2decisions
  • GFDDermatome1decision
  • ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect1decision
  • GEXPowered Laser Surgical Instrument1decision

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 1 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.

  • K100053Mattioli Pulse Two/Three Plus FamilyMattioli Engineering Corp. · 20102cite it
  • K032968Trsansderm Ionto SystemMattioli Engineering Corp. · 20032cite it
  • K042590Transderm Ionto System, MK 2Mattioli Engineering Corp. · 20042cite it

What has FDA decided for it lately?

  • K100053Mattioli Pulse Two/Three Plus FamilyMattioli Engineering Corp. · 2010
  • K042590Transderm Ionto System, MK 2Mattioli Engineering Corp. · 2004
  • K032968Trsansderm Ionto SystemMattioli Engineering Corp. · 2003
  • K965256DMS-1000C DermoabraderMattioli Engineering, Srl · 1996
  • K941838Multiple CO2 LaersMattioli Engineering, Srl · 1994

All 3 as Mattioli Engineering Corp. →All 2 as Mattioli Engineering, Srl →