510(k) Report

FDA applicant

Global USA Distribution, LLC

Minneapolis, MN4 decisions2008–20081 recall

FDA records 4 decisions for Global USA Distribution, LLC (Minneapolis, MN) in 2008: 4 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 11 predicates, 0 of them its own earlier devices. 1 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 Global USA Distribution, LLC’s devices, and how often a recall has named them.

FDA decisions per year

4in 2008

2008: 4
2008high 4 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2008

2008: 1
2008high 1 (2008) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Global USA Distribution, LLC by year, 2008–2026Sources: 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 Instrument4decisions

Whose devices does it build on?

Its devices cite 11 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K082033Nannolight Intense Pulsed Light SystemGlobal USA Distribution, LLC · 20081cites it

What has FDA decided for it lately?

  • K083272Skinclear Q-Switched ND:Yag LaserGlobal USA Distribution, LLC · 2008
  • K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC · 2008
  • K082033Nannolight Intense Pulsed Light SystemGlobal USA Distribution, LLC · 20081 recall
  • K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC · 2008

All 4 as Global USA Distribution, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K082033Sybaritic, NannoLight MP50. Model Numbers and Description: 1.) 304207-MP 220 Volt…Apr 12, 2008