510(k) · Cleared
ClearedLuminex LL Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Laser Systems, Inc. · NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Cleared on Jan 29, 2007 as substantially equivalent to K010175 (Microlight Corporation of America, 2002) and 2 other predicates after a 61-day review. Its family tree reaches back 4 generations to 2002.
- Decided
- Jan 29, 2007
- Review
- 61 days
- Class
- Class II
- Product code
- NHN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K010175 (2002). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK010175 Microlight 830 Laser SystemMicrolight Corporation of America · 2002
- 3 generations backK020657 Acculaser Pro Low Level Laser Therapy DeviceAcculaser, Inc. · 2002
- 2 generations backK030226 Thor Ddii 830CL3 Laser SystemThor Intl. · 2003
- 1 generation backK034009 LAPEX 2000Meridian Co., Ltd. · 2005
- This deviceK063574 Luminex LL Laser SystemMedical Laser Systems, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010175 | Microlight 830 Laser System | Microlight Corporation of America | 2002 | — |
| −3 | K020657 | Acculaser Pro Low Level Laser Therapy Device | Acculaser, Inc. | 2002 | — |
| −2 | K030226 | Thor Ddii 830CL3 Laser System | Thor Intl. | 2003 | — |
| −1 | K034009 | LAPEX 2000 | Meridian Co., Ltd. | 2005 | — |
| 0 (this device) | K063574 | Luminex LL Laser System | Medical Laser Systems, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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? (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 2…utic lasers currently in commercial distribution. These predicate devices include the Microlight Corporation of America, Inc., MicroLight 830 Laser System (K010175), the Acculaser, Inc. Acculaser Pro Low Level Laser System (K020657), and the Meridian Co., Ltd., Lapex 2000 (K034009). V… | 2002 |
| * | K020657 | Acculaser Pro Low Level Laser Therapy DeviceSummary page 2…vices include the Microlight Corporation of America, Inc., MicroLight 830 Laser System (K010175), the Acculaser, Inc. Acculaser Pro Low Level Laser System (K020657), and the Meridian Co., Ltd., Lapex 2000 (K034009). V. Summary of the Technical Characteristics of the Laser System a… | 2002 |
| * | K034009 | LAPEX 2000Summary page 2…a, Inc., MicroLight 830 Laser System (K010175), the Acculaser, Inc. Acculaser Pro Low Level Laser System (K020657), and the Meridian Co., Ltd., Lapex 2000 (K034009). V. Summary of the Technical Characteristics of the Laser System as Related to the Referenced Predicate Devices.… | 2005 |
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 5 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- None of the 5 ancestors has a recall.
- 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. 2007, 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?
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/K063574 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063574: Luminex LL 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/K063574
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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