510(k) · Cleared
ClearedIR Heat Lamp Systems: Icl 15 HFPL System, Icl 60 Plus HFPL System (Models 40, 100 and 250), Icl 100 Activo Scanner Syste
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Usa Laser Biotech, Inc. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Nov 17, 2004 as substantially equivalent to K001179 (Light Force Therapy, Inc., 2000) and 1 other predicate after an 89-day review. Its family tree reaches back 2 generations to 2000. 7 later devices descend from it.
- Decided
- Nov 17, 2004
- Review
- 89 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K001179 (2000). 7 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 1 generation backK023621 Bioflex Professional Therapy SystemMeditech International, Inc. · 2003
- This deviceK042256 IR Heat Lamp Systems: Icl 15 HFPL System, Icl 60 Plus HFPL System…Usa Laser Biotech, Inc. · 2004
- Descendant · cites it directly · 5 of its ownK101893 Nexus Biowave 7W Lite IR Lamp System, Nexus Biowave 10W Lite IR Lamp…Usa Laser Biotech, Inc. · 2011
- Descendant · cites it directly · 3 of its ownK132016 Lumix 3 Plus and Lumix 3 Ultra SystemTexas Applied Biomedical Services, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK171087 AXON IR Heat LampCrystal Medtech, LLC · 2017
- Descendant · 2 generations on · 0 of its ownK161198 Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK160947 LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR…Usa Laser Biotech, Inc. · 2016
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K101893Nexus Biowave 7W Lite IR Lamp System, Nexus Biowave 10W Lite IR Lamp System, Nexus…Usa Laser Biotech, Inc. · 2011 · cites it directly5descendants
- K132016Lumix 3 Plus and Lumix 3 Ultra SystemTexas Applied Biomedical Services, Inc. · 2014 · cites it directly3descendants
- K171087AXON IR Heat LampCrystal Medtech, LLC · 2017 · 2 generations on0descendants
- K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc. · 2016 · 2 generations on0descendants
- K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX…Usa Laser Biotech, Inc. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −1 | K023621 | Bioflex Professional Therapy System | Meditech International, Inc. | 2003 | — |
| 0 (this device) | K042256 | IR Heat Lamp Systems: Icl 15 HFPL System, Icl 60 Plus HFPL System (Models 40… | Usa Laser Biotech, Inc. | 2004 | — |
| +1 | K101893 | Nexus Biowave 7W Lite IR Lamp System, Nexus Biowave 10W Lite IR Lamp System… | Usa Laser Biotech, Inc. | 2011 | — |
| +1 | K132016 | Lumix 3 Plus and Lumix 3 Ultra System | Texas Applied Biomedical Services, Inc. | 2014 | — |
| +2 | K171087 | AXON IR Heat Lamp | Crystal Medtech, LLC | 2017 | — |
| +2 | K161198 | Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 | Usa Laser Biotech, Inc. | 2016 | — |
| +2 | K160947 | LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp… | Usa Laser Biotech, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K001179 | Super Nova, AcubeamSummary page 1…tic lamps that are currently in commercial distribution. These predicate devices include the Light Force Therapy, Inc. Super Nova and Acubeamn Systems (K001179) and the Meditech International Inc BioFlex Professional Therapy System (K023621).… | 2000 |
| * | K023621 | Bioflex Professional Therapy SystemSummary page 1…include the Light Force Therapy, Inc. Super Nova and Acubeamn Systems (K001179) and the Meditech International Inc BioFlex Professional Therapy System (K023621). & HUMAN SERVICES D~pARTFHEALTH… | 2003 |
What descends from it? (7)
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 4 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K101893 (Usa Laser Biotech, Inc., 2011) has gone furthest, with 5 descendants of its own.
- 12 other devices also cite its predicate K001179.
How does its category compare?
All ILY devicesILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 ICL IR Heat Lamp Systems, as listed above, are intended to emit energy in the 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/K042256 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042256: IR Heat Lamp Systems: Icl 15 HFPL System, Icl 60 Plus HFPL System (Models 40, 100 and 250), Icl 100 Activo Scanner Syste.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042256
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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