Excalibur Light Therapy System, Model SGIEX-04-001

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K041530 ↗

FDA Product Code

NHN

Device Class

Class II

Regulation

21 CFR Part 890.5500

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• Quantum Light Therapy System

  Class II

  FDA 510(k) K032816 Active Cleared 26 Mar 2004

• Excalibur IV Light Therapy System, Model SGEX4-001

  Class II

  FDA 510(k) K051631 Active Cleared 27 Jul 2005

• What is the Excalibur Light Therapy System used for?

  The Excalibur Light Therapy System is a powered light-based laser non-thermal instrument with non-heating effect, designed for adjunctive use in pain therapy. It is classified as a Class 2 medical device in the field of Physical Medicine.

• How is the Excalibur Light Therapy System supplied?

  The device is supplied as a non-heating lamp that is infrared, as described under the provisions of 21 CFR §890.5500. It is manufactured by Stargate International, Inc. and is authorized for FDA 510K clearance with K number K041530.

• What is the regulatory status of the Excalibur Light Therapy System?

  The Excalibur Light Therapy System has received FDA 510K clearance with a decision of Substantially Equivalent on October 14, 2004. It is classified as a Class 2 medical device with product code NHN in the field of Physical Medicine.

• Is the Excalibur Light Therapy System reusable or single-use?

  The device data does not specify whether the Excalibur Light Therapy System is reusable or single-use. For specific usage instructions and disposal information, please refer to the manufacturer's documentation or contact Stargate International, Inc. directly.