510(k) · Cleared
ClearedNeurolumen PN-1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurolumen, LLC · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Jan 21, 2015 as substantially equivalent to K082223 (Neurolumen, LLC, 2009) and 3 other predicates after a 180-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Jan 21, 2015
- Review
- 180 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K001179 (2000). 24 ancestors in all, the oldest K881114 (1988). 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 backK081141 Combocare 2000Xanacare Technologies, LLC · 2008
- This deviceK142025 Neurolumen PN-1000Neurolumen, LLC · 2015
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 | K081141 | Combocare 2000 | Xanacare Technologies, LLC | 2008 | — |
| 0 (this device) | K142025 | Neurolumen PN-1000 | Neurolumen, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 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 ILY? 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 ILY device
- #1 K242755 Medical Diode Laser Systems (VELAS II-30B…score 18.7 · 22 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 |
|---|---|---|---|
| * | K082223 | Neutrolumenpn System, Model 1000Summary page 4…y Class: |l Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Product Code: ILY, GZJ Claiming Equivalencé to: Trade Name: NeurolumenPN 510(k) Number: K082223 Regulatory Class: I Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Product Code: ILY, GZJ Trade Name: Terra… | 2009 |
| * | K061614 | Terraquant MQ2000 V. 5 and Handyrx MQ2007 LasersSummary page 7…23: 4 AA NiMH 1 Li-lon battery pack added batteries for improved charge density and cycle life. TENS Pulse K082223: identical Laser Classification K082223: Not present K061614: lila Laser classification testing to IEC 60825-1 rated laser and LED output at class 3R (llla). Equivalent to other predicate d… | 2006 |
| * | K071445 | Terraquant MQ2000 V.5 with the TQ-1TENSSummary page 5…ary Page 6 of 32 1361 W. Euless Blvd, Ste 99 Euless, TX 76039 PH: 817-864-9197 FAX: 817-684-1019 SYSTEC S INNOVATIVE yecyNOLOGIES .. 510(k) Number: K071445 Regulatory Class: I Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Product Code: ILY, GEX, GZJ Trade Name:… | 2007 |
| * | K081141 | Combocare 2000Summary page 8…Page 9 of 32 1361 W. Euless Blvd, Ste 99 Euless, TX 76039 PH: 817-864-9197 FAX: 817-684-1019 S5YSTEC & INNOVRTIVE yerpynOL OGIES 1.c K061614: 680nm K081141: 640nm K071445: 660nm IR LEDs K082223: 905nm 940nm K061614: 840nm K081141: 870nm K071445: 875nm The determination of substantia… | 2008 |
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 15 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- None of the 24 ancestors has a recall.
How does its category compare?
All ILY devicesILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · ILY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ILY
116in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ILY
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ILY
17in 2025
MAUDE reports naming product code ILY, 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 | 10 | 128 | 0 | 24 |
| 2008 | 16 | 165 | 0 | 20 |
| 2009 | 13 | 189 | 0 | 9 |
| 2010 | 8 | 185 | 1 | 7 |
| 2011 | 9 | 198 | 0 | 10 |
| 2012 | 11 | 130 | 3 | 7 |
| 2013 | 9 | 211 | 0 | 8 |
| 2014 | 11 | 153 | 0 | 0 |
| 2015 | 11 | 146 | 0 | 2 |
| 2016 | 8 | 214 | 0 | 2 |
| 2017 | 5 | 116 | 0 | 12 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 7 |
| 2020 | 1 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 2 | — | 4 | 2 |
| 2023 | 1 | — | 1 | 15 |
| 2024 | 1 | — | 0 | 19 |
| 2025 | 1 | — | 1 | 17 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The Neurolumen is indicated for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
The Neurolumen is also indicated for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-traumatic acute pain.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K142025 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142025: Neurolumen PN-1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142025
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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