510(k) Report

FDA applicant

Norseld Pty., Ltd.

Hot Springs, AR2 decisions2003–20040 recalls

FDA records 2 decisions for Norseld Pty., Ltd. (Hot Springs, AR) from 2003 to 2004: 2 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 14 predicates, 1 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 Norseld Pty., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Norseld Pty., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Norseld Pty., Ltd. 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

Whose devices does it build on?

Its devices cite 14 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K032397Dual Yellow Laser, Model Dual Yellow D10BNorseld Pty., Ltd. · 20041cites it
  • K023899Dual Yellow Laser, Model D10BNorseld Pty., Ltd. · 20031cites it

What has FDA decided for it lately?

  • K032397Dual Yellow Laser, Model Dual Yellow D10BNorseld Pty., Ltd. · 2004
  • K023899Dual Yellow Laser, Model D10BNorseld Pty., Ltd. · 2003

All 2 as Norseld Pty., Ltd. →