510(k) · Cleared
ClearedDynatron X3 , Dynatron XP IR Light Pad, D405 IR 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 Jul 25, 2005 as substantially equivalent to K031329 (Dynatronics Corp., 2003) after a 70-day review. Its family tree reaches back 3 generations to 2000. 1 later device descends from it.
- Decided
- Jul 25, 2005
- Review
- 70 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K001179 (2000). 7 ancestors in all, the oldest K941461 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 2 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 1 generation backK031329 Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared…Dynatronics Corp. · 2003
- This deviceK051261 Dynatron X3 , Dynatron XP IR Light Pad, D405 IR Light ProbeDynatronics Corp. · 2005
- Descendant · cites it directly · 0 of its ownK113250 Dynatron Tri-Wave Light Pad Dynatron Tri-Wave Light ProbeDynatronics Corp. · 2012
Most influential descendants
Showing 1 of 1 · See all- K113250Dynatron Tri-Wave Light Pad Dynatron Tri-Wave Light ProbeDynatronics Corp. · 2012 · 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 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −1 | K031329 | Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared Probe… | Dynatronics Corp. | 2003 | — |
| 0 (this device) | K051261 | Dynatron X3 , Dynatron XP IR Light Pad, D405 IR Light Probe | Dynatronics Corp. | 2005 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 |
|---|---|---|---|
| * | K031329 | Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared Probe (Optional…Summary page 1…ulation Nos.: 890.5500 Product Codes: ILY 2. PREDICATE DEVICE: Dynatron® SolarisTM D705 and accessory D880 IR Probe Cleared under K031329 (October 22, 2003) 3. PERFORMANCE STANDARDS: The Dynatron Solaris Series of devices conform to the applicable requirements o… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113250 | Dynatron Tri-Wave Light Pad Dynatron Tri-Wave Light Probe | 2012 | 0 |
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 5 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K113250 (Dynatronics Corp., 2012) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K031329.
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?
Infrared 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/K051261 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051261: Dynatron X3 , Dynatron XP IR Light Pad, D405 IR 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/K051261
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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