510(k) Report

FDA applicant

Stargate International, Inc.

Parker, CO3 decisions2004–20050 recalls

FDA records 3 decisions for Stargate International, Inc. (Parker, CO) from 2004 to 2005: 3 510(k) clearances. All are in product code NHN (Powered Light Based Laser Non-Thermal…). Its devices cite 6 predicates, 2 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, physical medicine panel, where it files most

How often FDA has decided Stargate International, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Stargate International, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Stargate International, 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?

  • NHNPowered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive…3decisions

Whose devices does it build on?

Its devices cite 6 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 2 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.

  • K032816Quantum Light Therapy SystemStargate International, Inc. · 20044cite it
  • K041530Excalibur Light Therapy System, Model Sgiex-04-001Stargate International, Inc. · 20043cite it

What has FDA decided for it lately?

  • K051631Excalibur IV Light Therapy System, Model SGEX4-001Stargate International, Inc. · 2005
  • K041530Excalibur Light Therapy System, Model Sgiex-04-001Stargate International, Inc. · 2004
  • K032816Quantum Light Therapy SystemStargate International, Inc. · 2004

All 3 as Stargate International, Inc. →