510(k) · Cleared
ClearedNexus Biowave 7W Lite IR Lamp System, Nexus Biowave 10W Lite IR Lamp System, Nexus Biowave 30W Pro IR Lamp System, Nexus
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 Feb 17, 2011 as substantially equivalent to K091726 (Usa Laser Biotech, Inc., 2009) and 2 other predicates after a 225-day review. Its family tree reaches back 4 generations to 2000. 5 later devices descend from it.
- Decided
- Feb 17, 2011
- Review
- 225 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K001179 (2000). 7 ancestors in all, the oldest K993685 (2000). 5 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 3 generations backK023621 Bioflex Professional Therapy SystemMeditech International, Inc. · 2003
- 2 generations backK052814 Lumina 1600, 3300 and 6600 SystemsUsa Laser Biotech, Inc. · 2005
- 1 generation backK091726 Nexus Xpulse 805 IR Lamp System, Nexus Xpulse 980 IR Lamp System…Usa Laser Biotech, Inc. · 2009
- This deviceK101893 Nexus Biowave 7W Lite IR Lamp System, Nexus Biowave 10W Lite IR Lamp…Usa Laser Biotech, Inc. · 2011
- 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
- Descendant · cites it directly · 0 of its ownK151629 Guardian 1000Quanta System Spa · 2015
- Descendant · cites it directly · 0 of its ownK151521 Phoenix Thera-Lase SystemPhoenix Thera-Lase Systems, LLC · 2015
Most influential descendants
Showing 5 of 5 · 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
- K151629Guardian 1000Quanta System Spa · 2015 · cites it directly0descendants
- K151521Phoenix Thera-Lase SystemPhoenix Thera-Lase Systems, LLC · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −3 | K023621 | Bioflex Professional Therapy System | Meditech International, Inc. | 2003 | — |
| −2 | K052814 | Lumina 1600, 3300 and 6600 Systems | Usa Laser Biotech, Inc. | 2005 | — |
| −1 | K091726 | Nexus Xpulse 805 IR Lamp System, Nexus Xpulse 980 IR Lamp System, Model 805, 980 | Usa Laser Biotech, Inc. | 2009 | — |
| 0 (this device) | K101893 | Nexus Biowave 7W Lite IR Lamp System, Nexus Biowave 10W Lite IR Lamp System… | Usa Laser Biotech, Inc. | 2011 | — |
| +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 | — |
| +1 | K151629 | Guardian 1000 | Quanta System Spa | 2015 | — |
| +1 | K151521 | Phoenix Thera-Lase System | Phoenix Thera-Lase Systems, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K091726 | Nexus Xpulse 805 IR Lamp System, Nexus Xpulse 980 IR Lamp System, Model 805, 980Summary page 2…rently in commercial distribution. These predicate devices include, but are not limited to, the USA Laser Biotech Inc. Nexus XPulse IR Heat Lamp Systems (K091726), the LUMINA 1600 Infrared Heat Lamp Therapy System (K052814), and ICL 60 Plus HFPL System (Models 40, 100, 250)… | 2009 |
| * | K052814 | Lumina 1600, 3300 and 6600 SystemsSummary page 2…clude, but are not limited to, the USA Laser Biotech Inc. Nexus XPulse IR Heat Lamp Systems (K091726), the LUMINA 1600 Infrared Heat Lamp Therapy System (K052814), and ICL 60 Plus HFPL System (Models 40, 100, 250) K042256 V. Summary of the Technical Characteristics of the Nexus… | 2005 |
| * | K042256 | IR Heat Lamp Systems: Icl 15 HFPL System, Icl 60 Plus HFPL System (Models 40, 100 and…Summary page 2…xus XPulse IR Heat Lamp Systems (K091726), the LUMINA 1600 Infrared Heat Lamp Therapy System (K052814), and ICL 60 Plus HFPL System (Models 40, 100, 250) K042256 V. Summary of the Technical Characteristics of the Nexus IR Lamp Systems as Related to the Referenced Predicate Devic… | 2004 |
What descends from it? (5)
5 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 11 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K171087 (Crystal Medtech, LLC, 2017) has gone furthest, with 0 descendants of its own.
How does its category compare?
All ILY devicesILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Nexus BiaWave Series IR Lamp 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/K101893 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101893: Nexus Biowave 7W Lite IR Lamp System, Nexus Biowave 10W Lite IR Lamp System, Nexus Biowave 30W Pro IR Lamp System, Nexus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101893
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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