510(k) · Cleared
ClearedTherapy US
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dmc Importação E Exportação DE Equipamentos Ltda · NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Cleared on Dec 12, 2025 as substantially equivalent to K241057 (Wuhan Guangdun Technology Co.,Ltd.., 2025) after a 143-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Dec 12, 2025
- Review
- 143 days
- Class
- Class II
- Product code
- NHN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K001179 (2000). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 5 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 4 generations backK032816 Quantum Light Therapy SystemStargate International, Inc. · 2004
- 3 generations backK041530 Excalibur Light Therapy System, Model Sgiex-04-001Stargate International, Inc. · 2004
- 2 generations backK050668 GRT Lite, Model 8-aGrt Solutions, Inc. · 2006
- 1 generation backK241057 Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)Wuhan Guangdun Technology Co.,Ltd.. · 2025
- This deviceK252273 Therapy USDmc Importação E Exportação DE Equipamentos Ltda · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −5 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −4 | K032816 | Quantum Light Therapy System | Stargate International, Inc. | 2004 | — |
| −3 | K041530 | Excalibur Light Therapy System, Model Sgiex-04-001 | Stargate International, Inc. | 2004 | — |
| −2 | K050668 | GRT Lite, Model 8-a | Grt Solutions, Inc. | 2006 | — |
| −1 | K241057 | Enhanced Handheld Pain Relief Laser Instrument (GD-P-E) | Wuhan Guangdun Technology Co.,Ltd.. | 2025 | — |
| 0 (this device) | 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 |
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? (1)
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 |
|---|---|---|---|
| * | K241057 | Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)Summary page 5…tion 21 CFR 890.5500, Class II Review Panel Physical Medicine PREDICATE DEVICE INFORMATION Predicate K241057 - Enhanced Handheld Pain Relief Laser Instrument (GD-P-E) - Wuhan Guangdun Technology Co.,Ltd.… | 2025 |
| † | K232813 | Therapy EC, Therapy XT | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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 6 companies; a new generation was cleared every 1.7 years on median.
- None of the 12 ancestors has a recall.
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?
Therapy US is generally 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/K252273 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252273: Therapy US.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252273
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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