510(k) · Cleared
ClearedElectro-Light Therapy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hill Laboratories Co. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Feb 11, 2010 as substantially equivalent to K072256 (Hill Laboratories Co., 2008) and 1 other predicate after a 374-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Feb 11, 2010
- Review
- 374 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K001179 (2000). 11 ancestors in all, the oldest K941461 (1995). No later device cites it as a predicate yet.
- Root · 5 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 4 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 3 generations backK031329 Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared…Dynatronics Corp. · 2003
- 2 generations backK062256 HF54 Combination Ultrasound Interferential and Premodulated…Hill Laboratories Co. · 2007
- 1 generation backK072256 HF54 Combination Ultrasound Interferential and Premodulated…Hill Laboratories Co. · 2008
- This deviceK090250 Electro-Light TherapyHill Laboratories Co. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −4 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −3 | K031329 | Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared Probe… | Dynatronics Corp. | 2003 | — |
| −2 | K062256 | HF54 Combination Ultrasound Interferential and Premodulated Stimulation System | Hill Laboratories Co. | 2007 | — |
| −1 | K072256 | HF54 Combination Ultrasound Interferential and Premodulated Stimulation System… | Hill Laboratories Co. | 2008 | — |
| 0 (this device) | K090250 | Electro-Light Therapy | Hill Laboratories Co. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 4 | 0 |
| 2004 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K072256 | HF54 Combination Ultrasound Interferential and Premodulated Stimulation System with…Summary page 3…510(k) Number Trade or Proprietary or Model Manufacturer Class Name K072256 HIF 54 with Optional Hands-free Hill Laboratories 2… | 2008 |
| * | K071445 | Terraquant MQ2000 V.5 with the TQ-1TENSSummary page 3…Laboratories 2 operation _ _ _ _ _ _ _ _ _ _ _ _ _ _ K07 1445 Terraquant Mq2000 V.5 With Medical Quant 2 ______________The… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 10 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- None of the 11 ancestors has a recall.
How does its category compare?
All ILY devicesILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
Electro-Light Therapy System is used to provide topical heating for:
* Temporary increases in local blood flow and circulation
* Temporary relief of minor muscle and joint aches
* Temporary relief of pain and stiffness
* Relaxation of muscles
* Temporary relief (or relaxation) of muscle spasms
* Temporary relief of minor pain and stiffness associated with arthritis
The Electro-Light Therapy system is intended to be used alone or at the same time with legally marketed powered muscle stimulators, TENS units or Interferential Current Therapy when used with the transparent Electro-Light electrode.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090250 · printed Nov 5, 2026
Cite this page
510(k) Report. “K090250: Electro-Light Therapy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K090250
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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