510(k) Report

FDA applicant

Big Sky Laser Technologies, Inc.

Bozeman, MT1 decision2002–20020 recalls

FDA records 1 decision for Big Sky Laser Technologies, Inc. (Bozeman, MT) in 2002: 1 510(k) clearance. All are in product code GEX (Powered Laser Surgical Instrument). 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 Big Sky Laser Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Big Sky Laser Technologies, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Big Sky Laser Technologies, Inc. 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

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.

  • K021304Prolite Pulsed Light SystemBig Sky Laser Technologies, Inc. · 20021cites it

What has FDA decided for it lately?

  • K021304Prolite Pulsed Light SystemBig Sky Laser Technologies, Inc. · 2002

The one decision as Big Sky Laser Technologies, Inc. →