510(k) · Cleared
ClearedBiobeam Narrow Band Light Therapy Devices
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Life Without Pain, LLC · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Feb 25, 2005 as substantially equivalent to K032229 (Quantum Devices, Inc., 2003) and 2 other predicates after a 136-day review. Its family tree reaches back 2 generations to 1998. 22 later devices descend from it.
- Decided
- Feb 25, 2005
- Review
- 136 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K974468 (1998). 4 ancestors in all. 22 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK974468 Photonic StimulatorBales Scientific, Inc. · 1998
- 1 generation backK032229 Quantum Warp 10 Light Delivery SystemQuantum Devices, Inc. · 2003
- This deviceK042813 Biobeam Narrow Band Light Therapy DevicesLife Without Pain, LLC · 2005
- Descendant · cites it directly · 15 of its ownK083580 Anti-Wrinkle Light, Model 1302 and Pain Therapy Light, Model 1301Led Intellectual Properties, LLC · 2009
- Descendant · 2 generations on · 10 of its ownK150098 LightStim Professional 2-Panel LightLed Intellectual Properties, LLC · 2015
- Descendant · 2 generations on · 4 of its ownK151333 LightStim for Pain LED BeltLed Intellectual Properties, LLC · 2015
- Descendant · 2 generations on · 3 of its ownK153399 LightStim Professional LED BedLed Intellectual Properties, LLC · 2016
- Descendant · 2 generations on · 3 of its ownK120582 HeatluxHome Skinovations, Ltd. · 2012
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K083580Anti-Wrinkle Light, Model 1302 and Pain Therapy Light, Model 1301Led Intellectual Properties, LLC · 2009 · cites it directly15descendants
- K150098LightStim Professional 2-Panel LightLed Intellectual Properties, LLC · 2015 · 2 generations on10descendants
- K151333LightStim for Pain LED BeltLed Intellectual Properties, LLC · 2015 · 2 generations on4descendants
- K153399LightStim Professional LED BedLed Intellectual Properties, LLC · 2016 · 2 generations on3descendants
- K120582HeatluxHome Skinovations, Ltd. · 2012 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K974468 | Photonic Stimulator | Bales Scientific, Inc. | 1998 | — |
| −1 | K032229 | Quantum Warp 10 Light Delivery System | Quantum Devices, Inc. | 2003 | — |
| 0 (this device) | K042813 | Biobeam Narrow Band Light Therapy Devices | Life Without Pain, LLC | 2005 | — |
| +1 | K083580 | Anti-Wrinkle Light, Model 1302 and Pain Therapy Light, Model 1301 | Led Intellectual Properties, LLC | 2009 | — |
| +2 | K150098 | LightStim Professional 2-Panel Light | Led Intellectual Properties, LLC | 2015 | — |
| +2 | K151333 | LightStim for Pain LED Belt | Led Intellectual Properties, LLC | 2015 | — |
| +2 | K153399 | LightStim Professional LED Bed | Led Intellectual Properties, LLC | 2016 | — |
| +2 | K120582 | Heatlux | Home Skinovations, Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2015 | 5 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K032229 | Quantum Warp 10 Light Delivery SystemSummary page 1…PREDICATE DEVICES Narrow Band, Near-IR Energy, Pain Therapy Devices are substantially equivalent to the Quantum WARP 10 Light Delivery System, 510(k) No. K032229, Light Force Therapy's SuperNova, 510(k) No. K022888, and Diomedics' Pain-X-2000. 5 10(k) No. K982546. 4. DEVI… | 2003 |
| * | K022888 | Acubeam, Super Nova, DioSummary page 1…Therapy Devices are substantially equivalent to the Quantum WARP 10 Light Delivery System, 510(k) No. K032229, Light Force Therapy's SuperNova, 510(k) No. K022888, and Diomedics' Pain-X-2000. 5 10(k) No. K982546. 4. DEVICE DESCRIPTION The Narrow Band, Near-IR Energy, Pain… | 2002 |
| * | K982546 | Phaser-2000Summary page 1…the Quantum WARP 10 Light Delivery System, 510(k) No. K032229, Light Force Therapy's SuperNova, 510(k) No. K022888, and Diomedics' Pain-X-2000. 5 10(k) No. K982546. 4. DEVICE DESCRIPTION The Narrow Band, Near-IR Energy, Pain Therapy Devices use LEDs to generate heat that all… | 1998 |
What descends from it? (22)
See all 224 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 7 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K083580 (Led Intellectual Properties, LLC, 2009) has gone furthest, with 15 descendants 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.
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?
Narrow Band, Near-IR Energy, Pain Therapy Devices emit energy in the Near-IR spectrum for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042813 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042813: Biobeam Narrow Band Light Therapy Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042813
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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