510(k) Report

FDA applicant

Blueshine Srl

Mestre, Venice, IT3 decisions2006–20120 recalls

FDA records 3 decisions for Blueshine Srl (Mestre, Venice, IT) from 2006 to 2012: 3 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and PDZ (Lasers For Temporary Increase Of Clear Nail In…). Its devices cite 5 predicates, 0 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 Blueshine Srl’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2009: 12012: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Blueshine Srl 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
  • PDZLasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K110375Blueshine's Gold SeriesBlueshine Srl · 20122cite it

What has FDA decided for it lately?

  • K110375Blueshine's Gold SeriesBlueshine Srl · 2012
  • K090297Blueshine Gold SeriesBlueshine Srl · 2009
  • K063060Blueshine Light Shine Systems, SP, Twin and Compact SPBlueshine Srl · 2006

All 3 as Blueshine Srl →