510(k) · Cleared
ClearedExcalibur Light Therapy System, Model Sgiex-04-001
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stargate International, Inc. · NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Cleared on Oct 14, 2004 as substantially equivalent to K012580 (Tuco Innovations, Inc., 2002) and 1 other predicate after a 128-day review. Its family tree reaches back 3 generations to 2000. 12 later devices descend from it.
- Decided
- Oct 14, 2004
- Review
- 128 days
- Class
- Class II
- Product code
- NHN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K001179 (2000). 4 ancestors in all. 12 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 2 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 1 generation backK032816 Quantum Light Therapy SystemStargate International, Inc. · 2004
- This deviceK041530 Excalibur Light Therapy System, Model Sgiex-04-001Stargate International, Inc. · 2004
- Descendant · cites it directly · 9 of its ownK050668 GRT Lite, Model 8-aGrt Solutions, Inc. · 2006
- Descendant · cites it directly · 6 of its ownK081141 Combocare 2000Xanacare Technologies, LLC · 2008
- Descendant · 2 generations on · 2 of its ownK083202 Combocare 2000Xanacare Technologies, LLC · 2008
- Descendant · 2 generations on · 1 of its ownK241057 Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)Wuhan Guangdun Technology Co.,Ltd.. · 2025
- Descendant · 2 generations on · 1 of its ownK083822 Laser TouchoneLaser Health Technologies, LLC · 2009
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K050668GRT Lite, Model 8-aGrt Solutions, Inc. · 2006 · cites it directly9descendants
- K081141Combocare 2000Xanacare Technologies, LLC · 2008 · cites it directly6descendants
- K083202Combocare 2000Xanacare Technologies, LLC · 2008 · 2 generations on2descendants
- K241057Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)Wuhan Guangdun Technology Co.,Ltd.. · 2025 · 2 generations on1descendant
- K083822Laser TouchoneLaser Health Technologies, LLC · 2009 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −2 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −1 | K032816 | Quantum Light Therapy System | Stargate International, Inc. | 2004 | — |
| 0 (this device) | K041530 | Excalibur Light Therapy System, Model Sgiex-04-001 | Stargate International, Inc. | 2004 | — |
| +1 | K050668 | GRT Lite, Model 8-a | Grt Solutions, Inc. | 2006 | — |
| +1 | K081141 | Combocare 2000 | Xanacare Technologies, LLC | 2008 | — |
| +2 | K083202 | Combocare 2000 | Xanacare Technologies, LLC | 2008 | — |
| +2 | K241057 | Enhanced Handheld Pain Relief Laser Instrument (GD-P-E) | Wuhan Guangdun Technology Co.,Ltd.. | 2025 | — |
| +2 | K083822 | Laser Touchone | Laser Health Technologies, LLC | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NHN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NHN device
- #1 K241057 Enhanced Handheld Pain Relief Laser Instrument…score 12.9 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K012580 | Erchonia PL2000Summary page 2…e Excalibur System establishes equivalence to include the following: PredtcAe DeviCe 51O(kl #arature Thco Erchonia PL3000 ......... . K012580 ...... Tuco Innovations Quantum System ........................... K… | 2002 |
| * | K032816 | Quantum Light Therapy SystemSummary page 2…onia PL3000 ......... . K012580 ...... Tuco Innovations Quantum System ........................... K032816 Stargate International V. Intended Use of the Device The Excalibur Light Therapy System is a non-heati… | 2004 |
What descends from it? (12)
See all 123 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K050668 (Grt Solutions, Inc., 2006) has gone furthest, with 9 descendants of its own.
- 4 other devices also cite its predicate K012580.
How does its category compare?
All NHN devicesNHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NHN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHN
416in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHN
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHN
1in 2025
MAUDE reports naming product code NHN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 3 | 260 | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 3 | 154 | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 3 | 117 | 0 | 0 |
| 2019 | 2 | — | 2 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 1 |
| 2022 | 3 | 416 | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041530 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041530: Excalibur Light Therapy System, Model Sgiex-04-001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041530
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026