510(k) · Cleared
ClearedThor Ddii 830CL3 Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thor Intl. · NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Cleared on Feb 10, 2003 as substantially equivalent to K010175 (Microlight Corporation of America, 2002) and 2 other predicates after a 19-day review. Its family tree reaches back 2 generations to 2002. 6 later devices descend from it.
- Decided
- Feb 10, 2003
- Review
- 19 days
- Class
- Class II
- Product code
- NHN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K010175 (2002). 3 ancestors in all. 6 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK010175 Microlight 830 Laser SystemMicrolight Corporation of America · 2002
- 1 generation backK020657 Acculaser Pro Low Level Laser Therapy DeviceAcculaser, Inc. · 2002
- This deviceK030226 Thor Ddii 830CL3 Laser SystemThor Intl. · 2003
- Descendant · cites it directly · 1 of its ownK241057 Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)Wuhan Guangdun Technology Co.,Ltd.. · 2025
- Descendant · cites it directly · 1 of its ownK034009 LAPEX 2000Meridian Co., Ltd. · 2005
- Descendant · 2 generations on · 0 of its ownK252273 Therapy USDmc Importação E Exportação DE Equipamentos Ltda · 2025
- Descendant · cites it directly · 0 of its ownK232813 Therapy EC, Therapy XTDmc Importacao E Exportacao DE Equipamentos Ltda · 2024
- Descendant · cites it directly · 0 of its ownK203337 PainTB, PainTJPtech Co., Ltd. · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K241057Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)Wuhan Guangdun Technology Co.,Ltd.. · 2025 · cites it directly1descendant
- K034009LAPEX 2000Meridian Co., Ltd. · 2005 · cites it directly1descendant
- K252273Therapy USDmc Importação E Exportação DE Equipamentos Ltda · 2025 · 2 generations on0descendants
- K232813Therapy EC, Therapy XTDmc Importacao E Exportacao DE Equipamentos Ltda · 2024 · cites it directly0descendants
- K203337PainTB, PainTJPtech Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010175 | Microlight 830 Laser System | Microlight Corporation of America | 2002 | — |
| −1 | K020657 | Acculaser Pro Low Level Laser Therapy Device | Acculaser, Inc. | 2002 | — |
| 0 (this device) | K030226 | Thor Ddii 830CL3 Laser System | Thor Intl. | 2003 | — |
| +1 | K241057 | Enhanced Handheld Pain Relief Laser Instrument (GD-P-E) | Wuhan Guangdun Technology Co.,Ltd.. | 2025 | — |
| +1 | K034009 | LAPEX 2000 | Meridian Co., Ltd. | 2005 | — |
| +2 | K252273 | Therapy US | Dmc Importação E Exportação DE Equipamentos Ltda | 2025 | — |
| +1 | K232813 | Therapy EC, Therapy XT | Dmc Importacao E Exportacao DE Equipamentos Ltda | 2024 | — |
| +1 | K203337 | PainTB, PainTJ | Ptech Co., Ltd. | 2022 | — |
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 |
| 2007 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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? (3)
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 |
|---|---|---|---|
| * | K010175 | Microlight 830 Laser SystemSummary page 1…eutic lasers currently in commercial distribution. These predicate devices include the MicroLight Corporation of America, Inc. MicroLight 830 Laser System (K010175), Acculaser, Inc. Acculaser Pro Low Level Laser System (K020657) and the MedX LCS System (K021985). These devices were cle… | 2002 |
| * | K020657 | Acculaser Pro Low Level Laser Therapy DeviceSummary page 1…te devices include the MicroLight Corporation of America, Inc. MicroLight 830 Laser System (K010175), Acculaser, Inc. Acculaser Pro Low Level Laser System (K020657) and the MedX LCS System (K021985). These devices were cleared for introduction into interstate commerce via the FD… | 2002 |
| * | K021985 | Medx LCS Laser SeriesSummary page 1…Corporation of America, Inc. MicroLight 830 Laser System (K010175), Acculaser, Inc. Acculaser Pro Low Level Laser System (K020657) and the MedX LCS System (K021985). These devices were cleared for introduction into interstate commerce via the FDA's 510(k) Notification process. The Ther… | 2002 |
What descends from it? (6)
4 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 1 year and passes through 3 companies; a new generation was cleared every 6 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K241057 (Wuhan Guangdun Technology Co.,Ltd.., 2025) has gone furthest, with 1 descendant of its own.
- 10 other devices also cite its predicate K010175.
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 THOR DDII 830CL3 Laser System is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030226 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030226: Thor Ddii 830CL3 Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030226
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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