510(k) · Cleared
ClearedDynatron Tri-Wave Light Pad Dynatron Tri-Wave Light Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dynatronics Corp. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Feb 9, 2012 as substantially equivalent to K051261 (Dynatronics Corp., 2005) and 1 other predicate after a 98-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Feb 9, 2012
- Review
- 98 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K001179 (2000). 8 ancestors in all, the oldest K941461 (1995). No later device cites it as a predicate yet.
- Root · 4 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 3 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 2 generations backK031329 Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared…Dynatronics Corp. · 2003
- 1 generation backK051261 Dynatron X3 , Dynatron XP IR Light Pad, D405 IR Light ProbeDynatronics Corp. · 2005
- This deviceK113250 Dynatron Tri-Wave Light Pad Dynatron Tri-Wave Light ProbeDynatronics Corp. · 2012
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 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −2 | K031329 | Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared Probe… | Dynatronics Corp. | 2003 | — |
| −1 | K051261 | Dynatron X3 , Dynatron XP IR Light Pad, D405 IR Light Probe | Dynatronics Corp. | 2005 | — |
| 0 (this device) | K113250 | Dynatron Tri-Wave Light Pad Dynatron Tri-Wave Light Probe | Dynatronics Corp. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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? (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 |
|---|---|---|---|
| * | K051261 | Dynatron X3 , Dynatron XP IR Light Pad, D405 IR Light ProbeSummary page 1…Class 1I Regulation Nos.: 890.5500 Product Codes: ILY 2. PREDICATE DEVICES: Dynatron Xp Infrared Pad, cleared under KO051261 (July 25, 2005) as the predicate for the Dynatron Tri-waveTM light pad D880 Infrared Probe, cleared under K03 1329 (Oct 22… | 2005 |
| * | K031329 | Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared Probe (Optional…Summary page 1…CES: Dynatron Xp Infrared Pad, cleared under KO051261 (July 25, 2005) as the predicate for the Dynatron Tri-waveTM light pad D880 Infrared Probe, cleared under K03 1329 (Oct 22, 2003) as predicate for the Dynatron Tri-waveTM light probe 3. DESCRIPTION: The Dynatron Tri-waveTM light pad and… | 2003 |
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 12 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- None of the 8 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. 2012, 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?
Light therapy to provide topical heating for:
Temporary increase in local blood circulation
Temporary relief of minor muscle and joint aches, pains and stiffness
Relaxation of muscles
Muscle spasms
Minor pain and stiffness associated with arthritis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113250 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113250: Dynatron Tri-Wave Light Pad Dynatron Tri-Wave Light Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113250
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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