510(k) Report

FDA applicant

North American Clinical Lasers, Ltd.

Denver, CO1 decision2006–20060 recalls

FDA records 1 decision for North American Clinical Lasers, Ltd. (Denver, CO) in 2006: 1 510(k) clearance. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 1 predicate, 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 North American Clinical Lasers, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for North American Clinical Lasers, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — North American Clinical Lasers, 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 Instrument1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K062248Azuryt Model CTL 1401, CO2 Surgical Laser SystemNorth American Clinical Lasers, Ltd. · 2006

The one decision as North American Clinical Lasers, Ltd. →