510(k) · Cleared
ClearedHeatlux
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Home Skinovations, Ltd. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Jul 6, 2012 as substantially equivalent to K032229 (Quantum Devices, Inc., 2003) and 3 other predicates after a 130-day review. Its family tree reaches back 5 generations to 1998. 3 later devices descend from it.
- Decided
- Jul 6, 2012
- Review
- 130 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K974468 (1998). 14 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK974468 Photonic StimulatorBales Scientific, Inc. · 1998
- 4 generations backK032229 Quantum Warp 10 Light Delivery SystemQuantum Devices, Inc. · 2003
- 3 generations backK043055 Terraquant MQ2000 Laser Therapy DeviceEscada International, Inc. · 2005
- 2 generations backK061614 Terraquant MQ2000 V. 5 and Handyrx MQ2007 LasersEscada International, Inc. · 2006
- 1 generation backK083580 Anti-Wrinkle Light, Model 1302 and Pain Therapy Light, Model 1301Led Intellectual Properties, LLC · 2009
- This deviceK120582 HeatluxHome Skinovations, Ltd. · 2012
- Descendant · cites it directly · 1 of its ownK150175 HeatLux Pro IHome Skinovations, Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK162763 Vevazz LED Heat LampVevazz, LLC · 2017
- Descendant · 2 generations on · 0 of its ownK152087 HeatLux Pro IIHome Skinovations, Ltd. · 2016
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K974468 | Photonic Stimulator | Bales Scientific, Inc. | 1998 | — |
| −4 | K032229 | Quantum Warp 10 Light Delivery System | Quantum Devices, Inc. | 2003 | — |
| −3 | K043055 | Terraquant MQ2000 Laser Therapy Device | Escada International, Inc. | 2005 | — |
| −2 | K061614 | Terraquant MQ2000 V. 5 and Handyrx MQ2007 Lasers | Escada International, Inc. | 2006 | — |
| −1 | K083580 | Anti-Wrinkle Light, Model 1302 and Pain Therapy Light, Model 1301 | Led Intellectual Properties, LLC | 2009 | — |
| 0 (this device) | K120582 | Heatlux | Home Skinovations, Ltd. | 2012 | — |
| +1 | K150175 | HeatLux Pro I | Home Skinovations, Ltd. | 2015 | — |
| +1 | K162763 | Vevazz LED Heat Lamp | Vevazz, LLC | 2017 | — |
| +2 | K152087 | HeatLux Pro II | Home Skinovations, Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K032229 | Quantum Warp 10 Light Delivery SystemSummary page 1…Regulation Name: Infrared lamp Regulatory Class: Class H1 Product Code: WLY Predicate devices * Quantum WARP 10 Light Delivery system by Quantum Devices Inc. K032229. * HYR Pain Relief Device by HYR LLC, K101716. " Tanda Restore, by Pharos Life Corporation, K090008. * LightStim, by… | 2003 |
| * | K101716 | HVR Pain Relief DeviceSummary page 1…ss H1 Product Code: WLY Predicate devices * Quantum WARP 10 Light Delivery system by Quantum Devices Inc. K032229. * HYR Pain Relief Device by HYR LLC, K101716. " Tanda Restore, by Pharos Life Corporation, K090008. * LightStim, by LED Intellectual Properties LLC, K(083580. Intended… | 2011 |
| * | K090008 | Tanda Restore, Model PtscsSummary page 1…ARP 10 Light Delivery system by Quantum Devices Inc. K032229. * HYR Pain Relief Device by HYR LLC, K101716. " Tanda Restore, by Pharos Life Corporation, K090008. * LightStim, by LED Intellectual Properties LLC, K(083580. Intended use: HeatLux is over the counter hand held device in… | 2009 |
| * | K083580 | Anti-Wrinkle Light, Model 1302 and Pain Therapy Light, Model 1301Summary page 1…32229. * HYR Pain Relief Device by HYR LLC, K101716. " Tanda Restore, by Pharos Life Corporation, K090008. * LightStim, by LED Intellectual Properties LLC, K(083580. Intended use: HeatLux is over the counter hand held device intended to emit energy in the visible and near JR spectrum… | 2009 |
What descends from it? (3)
2 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 14 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K150175 (Home Skinovations, Ltd., 2015) has gone furthest, with 1 descendant of its own.
- 14 other devices also cite its predicate K032229.
How does its category compare?
All ILY devicesILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
HeatLux is over the counter hand held device intended to emit energy in the visible and near 1k spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscular and joint pain and stiffniess, minor arthritis pain or muscle spasm, the temporary increase in local and blood circulation, and temporary relaxation of muscles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120582 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120582: Heatlux.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120582
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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