510(k) Report

FDA applicant

Medical Laser Technologies, Ltd.

Inverkeithing,Fife, GB4 decisions1998–20030 recalls

FDA records 4 decisions for Medical Laser Technologies, Ltd. (Inverkeithing,Fife, GB) from 1998 to 2003: 4 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 4 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Medical Laser Technologies, LLC”.

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 Medical Laser Technologies, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medical Laser Technologies, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medical Laser Technologies, 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 Instrument4decisions

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 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.

  • K032599Medical Laser Technologies, LLC MTL Erbium:Yag Laser SystemMedical Laser Technologies, LLC · 20036cite it
  • K990902Modification of MLT R694 Ruby Laser SystemMedical Laser Technologies, Ltd. · 19993cite it
  • K980187MLT R694 Ruby Laser SystemMedical Laser Technologies, Ltd. · 19981cites it

What has FDA decided for it lately?

  • K032599Medical Laser Technologies, LLC MTL Erbium:Yag Laser SystemMedical Laser Technologies, LLC · 2003
  • K990902Modification of MLT R694 Ruby Laser SystemMedical Laser Technologies, Ltd. · 1999
  • K982548MLT 30 LaserMedical Laser Technologies, Ltd. · 1998
  • K980187MLT R694 Ruby Laser SystemMedical Laser Technologies, Ltd. · 1998

All 3 as Medical Laser Technologies, Ltd. →The one decision as Medical Laser Technologies, LLC →