510(k) · Cleared
ClearedLuminex Infrared Lamp System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Laser Systems, Inc. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Oct 23, 2008 as substantially equivalent to K033923 (Thor Intl., 2004) and 2 other predicates after a 17-day review. Its family tree reaches back 6 generations to 1988. 1 later device descends from it.
- Decided
- Oct 23, 2008
- Review
- 17 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K875052 (1988). 18 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK875052 TDP, Lark Brand and Mit LampI.E.C. Co. · 1988
- 5 generations backK020851 TDP Heat Lamp or Infrared Heating Lamp, Models CQG-S1, CQG-111A/B…C&H International · 2002
- 4 generations backK024179 Palomar LightcubePalomar Medical Products, Inc. · 2003
- 3 generations backK032787 Neurolase, Models 150V, 150C, 1064Spectrum Laser & Technologies · 2003
- 2 generations backK033986 MLT-1000 IR Laser SystemMedical Laser Therapeutics LP · 2004
- 1 generation backK053473 Maestro MDTL Laser SystemAdvanced Medical Technologies, Inc. · 2006
- This deviceK082969 Luminex Infrared Lamp SystemMedical Laser Systems, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK123177 Stimlase 2000 Low Level Laser Therapy SystemLaserstim, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K123177Stimlase 2000 Low Level Laser Therapy SystemLaserstim, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K875052 | TDP, Lark Brand and Mit Lamp | I.E.C. Co. | 1988 | — |
| −5 | K020851 | TDP Heat Lamp or Infrared Heating Lamp, Models CQG-S1, CQG-111A/B, CQG-222A/B… | C&H International | 2002 | — |
| −4 | K024179 | Palomar Lightcube | Palomar Medical Products, Inc. | 2003 | — |
| −3 | K032787 | Neurolase, Models 150V, 150C, 1064 | Spectrum Laser & Technologies | 2003 | — |
| −2 | K033986 | MLT-1000 IR Laser System | Medical Laser Therapeutics LP | 2004 | — |
| −1 | K053473 | Maestro MDTL Laser System | Advanced Medical Technologies, Inc. | 2006 | — |
| 0 (this device) | K082969 | Luminex Infrared Lamp System | Medical Laser Systems, Inc. | 2008 | — |
| +1 | K123177 | Stimlase 2000 Low Level Laser Therapy System | Laserstim, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (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 |
|---|---|---|---|
| * | K033923 | TH0R Ddii IR Lamp SystemSummary page 2…f muscle. IV. Predicate Devices Predicate devices to the Luminex Infrared Lamp System include, but are not limited to, the Thor DDII IR Lamp System (K033923), the Maestro MDTL Laser System (K053473), and the Vectra Genisys Laser System (K040662). V. Summary of the Technica… | 2004 |
| * | K053473 | Maestro MDTL Laser SystemSummary page 2…edicate devices to the Luminex Infrared Lamp System include, but are not limited to, the Thor DDII IR Lamp System (K033923), the Maestro MDTL Laser System (K053473), and the Vectra Genisys Laser System (K040662). V. Summary of the Technical Characteristics of the Luminex System as… | 2006 |
| * | K040662 | Vectra Genisys (Module & Transportable) and Intelect XT (Module & Transportable) Laser…Summary page 2…stem include, but are not limited to, the Thor DDII IR Lamp System (K033923), the Maestro MDTL Laser System (K053473), and the Vectra Genisys Laser System (K040662). V. Summary of the Technical Characteristics of the Luminex System as Related to the Referenced Predicate Devices.… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123177 | Stimlase 2000 Low Level Laser Therapy System | 2013 | 0 |
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 20 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- None of the 18 ancestors has a recall.
- Of its descendants, K123177 (Laserstim, Inc., 2013) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K033923.
How does its category compare?
All ILY devicesILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Luminex Infrared Lamp System is intended to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and/or the temporary relaxation of muscle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082969 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082969: Luminex Infrared Lamp System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082969
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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