510(k) · Cleared
ClearedEnhanced Handheld Pain Relief Laser Instrument (GD-P-E)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wuhan Guangdun Technology Co.,Ltd.. · NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Cleared on Jan 24, 2025 as substantially equivalent to K050668 (Grt Solutions, Inc., 2006) and 3 other predicates after a 281-day review. Its family tree reaches back 5 generations to 2000. 1 later device descends from it.
- Decided
- Jan 24, 2025
- Review
- 281 days
- Class
- Class II
- Product code
- NHN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K001179 (2000). 11 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 4 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 3 generations backK032816 Quantum Light Therapy SystemStargate International, Inc. · 2004
- 2 generations backK041530 Excalibur Light Therapy System, Model Sgiex-04-001Stargate International, Inc. · 2004
- 1 generation backK050668 GRT Lite, Model 8-aGrt Solutions, Inc. · 2006
- This deviceK241057 Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)Wuhan Guangdun Technology Co.,Ltd.. · 2025
- Descendant · cites it directly · 0 of its ownK252273 Therapy USDmc Importação E Exportação DE Equipamentos Ltda · 2025
Most influential descendants
Showing 1 of 1 · See all- K252273Therapy USDmc Importação E Exportação DE Equipamentos Ltda · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −4 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −3 | K032816 | Quantum Light Therapy System | Stargate International, Inc. | 2004 | — |
| −2 | K041530 | Excalibur Light Therapy System, Model Sgiex-04-001 | Stargate International, Inc. | 2004 | — |
| −1 | K050668 | GRT Lite, Model 8-a | Grt Solutions, Inc. | 2006 | — |
| 0 (this device) | K241057 | Enhanced Handheld Pain Relief Laser Instrument (GD-P-E) | Wuhan Guangdun Technology Co.,Ltd.. | 2025 | — |
| +1 | K252273 | Therapy US | Dmc Importação E Exportação DE Equipamentos Ltda | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 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 K252273 Therapy USscore 12.0 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K050668 | GRT Lite, Model 8-aSummary page 6…1 of 4 Manufacturer: GRT Solutions, Inc. Trade/Device Name: GRT LITE Model PRO-8A 510(k) number: K050668 Predicate Device 2: Manufacturer: TUCO Innovations, Inc. Trade/Device Name: TUCO Erchonia® PL200… | 2006 |
| * | K012580 | Erchonia PL2000Summary page 6…050668 Predicate Device 2: Manufacturer: TUCO Innovations, Inc. Trade/Device Name: TUCO Erchonia® PL2000 510(k) number: K012580 Predicate Device 3: Manufacturer: THØR International Ltd. Trade/Device Name: THØR DDII 830CL3 Las… | 2002 |
| * | K030226 | Thor Ddii 830CL3 Laser SystemSummary page 6…Predicate Device 3: Manufacturer: THØR International Ltd. Trade/Device Name: THØR DDII 830CL3 Laser System 510(k) number: K030226 Predicate Device 4: Manufacturer: Erchonia Corporation Trade/Device Name: Erchonia® XLR8 510(k) n… | 2003 |
| * | K130996 | Erchonia EmergeSummary page 6…K030226 Predicate Device 4: Manufacturer: Erchonia Corporation Trade/Device Name: Erchonia® XLR8 510(k) number: K130996 Device Description The GD-P-E Enhanced Handheld Pain Relief Laser Instrument consists of a LCD, button, battery, power charger… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252273 | Therapy US | 2025 | 0 |
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 25 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K252273 (Dmc Importação E Exportação DE Equipamentos Ltda, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K050668.
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. 2025, this device’s year, is highlighted.
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 GD-P-E Enhanced Handheld Pain Relief Laser Instrument generally indicated:
- adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin;
- adjunctive use in providing temporary relief of minor chronic pain associated with Carpal Tunnel Syndrome (CTS)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241057 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241057: Enhanced Handheld Pain Relief Laser Instrument (GD-P-E).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241057
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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