# K041530: Excalibur Light Therapy System, Model Sgiex-04-001

- Pathway: 510(k) (Traditional)
- Applicant: Stargate International, Inc.
- Decided: Oct 14, 2004 after 128 days
- Product code: NHN (Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy)
- Device class: 2
- Regulation: 21 CFR 890.5500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K001179 (2000). 4 ancestors in all.
12 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012580: Erchonia PL2000, Tuco Innovations, Inc. (2002) Summary page 2.
- K032816: Quantum Light Therapy System, Stargate International, Inc. (2004) Summary page 2.

## Most influential descendants
- K050668: GRT Lite, Model 8-a (2006), 9 descendants of its own
- K081141: Combocare 2000 (2008), 6 descendants of its own
- K083202: Combocare 2000 (2008), 2 descendants of its own
- K241057: Enhanced Handheld Pain Relief Laser Instrument (GD-P-E) (2025), 1 descendant of its own
- K083822: Laser Touchone (2009), 1 descendant of its own

## Indications for use
The Excalibur Light Therapy System is a non-heating lamp, infrared as described under the provisions of 21 CFR §890.5500 and is indicated for: Adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.

Source page: https://510kreport.com/device/K041530
Methodology: https://510kreport.com/methodology