510(k) · Cleared
ClearedMedx LCS Laser Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medx Electronics, Inc. · NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Cleared on Sep 10, 2002 as substantially equivalent to K010175 (Microlight Corporation of America, 2002) after an 84-day review. Its family tree reaches back 1 generation to 2002. 9 later devices descend from it.
- Decided
- Sep 10, 2002
- Review
- 84 days
- Class
- Class II
- Product code
- NHN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010175 (2002). 9 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK010175 Microlight 830 Laser SystemMicrolight Corporation of America · 2002
- This deviceK021985 Medx LCS Laser SeriesMedx Electronics, Inc. · 2002
- Descendant · cites it directly · 6 of its ownK030226 Thor Ddii 830CL3 Laser SystemThor Intl. · 2003
- 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 ownK034009 LAPEX 2000Meridian Co., Ltd. · 2005
- Descendant · 3 generations on · 0 of its ownK252273 Therapy USDmc Importação E Exportação DE Equipamentos Ltda · 2025
- Descendant · 2 generations on · 0 of its ownK232813 Therapy EC, Therapy XTDmc Importacao E Exportacao DE Equipamentos Ltda · 2024
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K030226Thor Ddii 830CL3 Laser SystemThor Intl. · 2003 · cites it directly6descendants
- K241057Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)Wuhan Guangdun Technology Co.,Ltd.. · 2025 · 2 generations on1descendant
- K034009LAPEX 2000Meridian Co., Ltd. · 2005 · 2 generations on1descendant
- K252273Therapy USDmc Importação E Exportação DE Equipamentos Ltda · 2025 · 3 generations on0descendants
- K232813Therapy EC, Therapy XTDmc Importacao E Exportacao DE Equipamentos Ltda · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010175 | Microlight 830 Laser System | Microlight Corporation of America | 2002 | — |
| 0 (this device) | K021985 | Medx LCS Laser Series | Medx Electronics, Inc. | 2002 | — |
| +1 | K030226 | Thor Ddii 830CL3 Laser System | Thor Intl. | 2003 | — |
| +2 | K241057 | Enhanced Handheld Pain Relief Laser Instrument (GD-P-E) | Wuhan Guangdun Technology Co.,Ltd.. | 2025 | — |
| +2 | K034009 | LAPEX 2000 | Meridian Co., Ltd. | 2005 | — |
| +3 | K252273 | Therapy US | Dmc Importação E Exportação DE Equipamentos Ltda | 2025 | — |
| +2 | K232813 | Therapy EC, Therapy XT | Dmc Importacao E Exportacao DE Equipamentos Ltda | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 3 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K010175 | Microlight 830 Laser System | 2002 |
What descends from it? (9)
3 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?
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 MedX LCS Laser Series 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/K021985 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021985: Medx LCS Laser Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021985
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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