510(k) Report

FDA applicant

Espansione Marketing S.P.A

S. Lazzaro Di Savena, Bologna, IT3 decisions2007–20130 recalls

FDA records 3 decisions for Espansione Marketing S.P.A (S. Lazzaro Di Savena, Bologna, IT) from 2007 to 2013: 3 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and OHS (Light Based Over The Counter Wrinkle Reduction). Its devices cite 12 predicates, 2 of them its own earlier devices. 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, general and plastic surgery panel, where it files most

How often FDA has decided Espansione Marketing S.P.A’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2007: 12010: 12013: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Espansione Marketing S.P.A 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?

  • GEXPowered Laser Surgical Instrument2decisions
  • OHSLight Based Over The Counter Wrinkle Reduction1decision

Whose devices does it build on?

Its devices cite 12 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 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.

  • K070494Epi-C PlusEspansione Marketing S.P.A · 20071cites it
  • K092734E-Light LineEspansione Marketing S.P.A · 20101cites it
  • K124064Young AgainEspansione Marketing S.P.A · 20131cites it

What has FDA decided for it lately?

  • K124064Young AgainEspansione Marketing S.P.A · 2013
  • K092734E-Light LineEspansione Marketing S.P.A · 2010
  • K070494Epi-C PlusEspansione Marketing S.P.A · 2007

All 3 as Espansione Marketing S.P.A →