510(k) · Cleared
ClearedLumix 3 Plus and Lumix 3 Ultra System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Texas Applied Biomedical Services, Inc. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Jun 2, 2014 as substantially equivalent to K042256 (Usa Laser Biotech, Inc., 2004) after a 336-day review. Its family tree reaches back 3 generations to 2000. 3 later devices descend from it.
- Decided
- Jun 2, 2014
- Review
- 336 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K001179 (2000). 3 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 2 generations backK023621 Bioflex Professional Therapy SystemMeditech International, Inc. · 2003
- 1 generation backK042256 IR Heat Lamp Systems: Icl 15 HFPL System, Icl 60 Plus HFPL System…Usa Laser Biotech, Inc. · 2004
- This deviceK132016 Lumix 3 Plus and Lumix 3 Ultra SystemTexas Applied Biomedical Services, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK171087 AXON IR Heat LampCrystal Medtech, LLC · 2017
- Descendant · cites it directly · 0 of its ownK161198 Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc. · 2016
- Descendant · cites it directly · 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
Most influential descendants
Showing 3 of 3 · See all- K171087AXON IR Heat LampCrystal Medtech, LLC · 2017 · cites it directly0descendants
- K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc. · 2016 · cites it directly0descendants
- K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX…Usa Laser Biotech, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −2 | K023621 | Bioflex Professional Therapy System | Meditech International, Inc. | 2003 | — |
| −1 | K042256 | IR Heat Lamp Systems: Icl 15 HFPL System, Icl 60 Plus HFPL System (Models 40… | Usa Laser Biotech, Inc. | 2004 | — |
| 0 (this device) | K132016 | Lumix 3 Plus and Lumix 3 Ultra System | Texas Applied Biomedical Services, Inc. | 2014 | — |
| +1 | K171087 | AXON IR Heat Lamp | Crystal Medtech, LLC | 2017 | — |
| +1 | K161198 | Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 | Usa Laser Biotech, Inc. | 2016 | — |
| +1 | 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 |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K042256 | IR Heat Lamp Systems: Icl 15 HFPL System, Icl 60 Plus HFPL System (Models 40, 100 and…Summary page 3…a list of the predicate devices cleared by the FDA via 510K Notification process. 510(k) Number Predicate Device Name Manufacturer K042256 ICL 60 Plus HFPL System USA Laser Biotech, Inc. V. Summary of the Technical Characteristics of the Lumix… | 2004 |
What descends from it? (3)
3 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 4 companies; a new generation was cleared every 2.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K171087 (Crystal Medtech, LLC, 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K042256.
How does its category compare?
All ILY devicesILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Lumix 3 100W Plus and Lumix 3 250W Ultra Systems 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/K132016 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132016: Lumix 3 Plus and Lumix 3 Ultra System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132016
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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