510(k) · Cleared
ClearedDynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared Probe (Optional Accessory)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dynatronics Corp. · IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Cleared on Oct 22, 2003 as substantially equivalent to K950349 (Dynatronics Corp., 1995) and 4 other predicates after a 177-day review. Its family tree reaches back 2 generations to 2000. 37 later devices descend from it.
- Decided
- Oct 22, 2003
- Review
- 177 days
- Class
- Class II
- Product code
- IMI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K001179 (2000). 6 ancestors in all, the oldest K941461 (1995). 37 later devices descend from it, 7 citing it directly.
- Root · 2 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 1 generation backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- This deviceK031329 Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared…Dynatronics Corp. · 2003
- Descendant · cites it directly · 28 of its ownK040729 Solaris D890 Therapy ProbeDynatronics Corp. · 2004
- Descendant · cites it directly · 13 of its ownK043586 Laser Sys*Stim 540, Model ME 540Mettler Electronics Corp. · 2005
- Descendant · 2 generations on · 12 of its ownK050070 K-Laser, Models 3,4,4D,6DEltech S.R.L · 2005
- Descendant · 2 generations on · 9 of its ownK113017 Sys*Stim 240Mettler Electronics Corp. · 2012
- Descendant · 3 generations on · 8 of its ownK070400 LC Therapy, Model LCT-1000Litecure, LLC · 2007
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 37 · See all- K040729Solaris D890 Therapy ProbeDynatronics Corp. · 2004 · cites it directly28descendants
- K043586Laser Sys*Stim 540, Model ME 540Mettler Electronics Corp. · 2005 · cites it directly13descendants
- K050070K-Laser, Models 3,4,4D,6DEltech S.R.L · 2005 · 2 generations on12descendants
- K113017Sys*Stim 240Mettler Electronics Corp. · 2012 · 2 generations on9descendants
- K070400LC Therapy, Model LCT-1000Litecure, LLC · 2007 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −1 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| 0 (this device) | K031329 | Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared Probe… | Dynatronics Corp. | 2003 | — |
| +1 | K040729 | Solaris D890 Therapy Probe | Dynatronics Corp. | 2004 | — |
| +1 | K043586 | Laser Sys*Stim 540, Model ME 540 | Mettler Electronics Corp. | 2005 | — |
| +2 | K050070 | K-Laser, Models 3,4,4D,6D | Eltech S.R.L | 2005 | — |
| +2 | K113017 | Sys*Stim 240 | Mettler Electronics Corp. | 2012 | — |
| +3 | K070400 | LC Therapy, Model LCT-1000 | Litecure, LLC | 2007 | — |
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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 6 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 IMI? 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 IMI device
- #1 K240788 Ultrasound Stimulatorscore 10.4 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K950349 | Dynatron 950Summary page 1…, 890.5860 and 890.5500 Product Codes: GZJ, IMI, IPF, IMG, LIH and ILY 2. PREDICATE DEVICES: Solaris 709 - Previously Dynatron 950, cleared under K950349 (Sep 13, 1995); Solaris 708 - Previously Dynatron 850, cleared under K941461 (Sep 01, 1995); Solaris 706 - Previous… | 1995 |
| * | K941461 | Dynatron 850Summary page 1…LY 2. PREDICATE DEVICES: Solaris 709 - Previously Dynatron 950, cleared under K950349 (Sep 13, 1995); Solaris 708 - Previously Dynatron 850, cleared under K941461 (Sep 01, 1995); Solaris 706 - Previously Dynatron 650, cleared under K950348 (Sep 13, 1995); Solaris 705 - Previous… | 1995 |
| * | K950348 | Dynatron 650Summary page 1…r K950349 (Sep 13, 1995); Solaris 708 - Previously Dynatron 850, cleared under K941461 (Sep 01, 1995); Solaris 706 - Previously Dynatron 650, cleared under K950348 (Sep 13, 1995); Solaris 705 - Previously Dynatron 550, cleared under K94 1577 (Sep 0 1, 1995); Solaris D880 Infrare… | 1995 |
| * | K941577 | Dynatron 550Summary page 1…r K941461 (Sep 01, 1995); Solaris 706 - Previously Dynatron 650, cleared under K950348 (Sep 13, 1995); Solaris 705 - Previously Dynatron 550, cleared under K94 1577 (Sep 0 1, 1995); Solaris D880 Infrared Probe - SE to MedX 1000 Series, cleared under KO20017… | 1995 |
| * | K020017 | Medx 1000 Series | 2002 |
What descends from it? (37)
See all 377 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040729 | Solaris D890 Therapy Probe | 2004 | 28 |
| K043586 | Laser Sys*Stim 540, Model ME 540 | 2005 | 13 |
| K062256 | HF54 Combination Ultrasound Interferential and Premodulated Stimulation System | 2007 | 2 |
| K120835 | Dynatron Thermostim Probe-Done | 2012 | 1 |
| K051261 | Dynatron X3 , Dynatron XP IR Light Pad, D405 IR Light Probe | 2005 | 1 |
| K113250 | Dynatron Tri-Wave Light Pad Dynatron Tri-Wave Light Probe | 2012 | 0 |
| K051680 | Dynatron DX2 Traction Unit | 2005 | 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 3 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K040729 (Dynatronics Corp., 2004) has gone furthest, with 28 descendants of its own.
How does its category compare?
All IMI devicesIMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IMI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IMI
150in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IMI
2in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IMI
2in 2025
MAUDE reports naming product code IMI, 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 | 1 | — | 0 | 1 |
| 2008 | 0 | — | 2 | 2 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 9 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 3 | 150 | 0 | 2 |
| 2017 | 1 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 7 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 1 | — | 0 | 4 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Hi Volt, Russian, and Biphasic modes of stimulation are all forms of electrical muscle stimulation therapy available with the Solaris 709, 708, 706 & 705 and indicated for: Relaxation of muscle spasms Prevention or retardation of disuse atrophy increasing local blood circulation Muscle re-education Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Maintaining or increasing range of motion The Direct Current mode of…
Read the full statement (228 words)
Hi Volt, Russian, and Biphasic modes of stimulation are all forms of electrical muscle stimulation therapy available with the Solaris 709, 708, 706 & 705 and indicated for:
Relaxation of muscle spasms
Prevention or retardation of disuse atrophy
increasing local blood circulation
Muscle re-education
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Maintaining or increasing range of motion
The Direct Current mode of stimulation is also a form of electrical muscle stimulation therapy available with the Solaris 709, 708, 706 & 705 and indicated for:
Relaxation of muscle spasms
iFC, Premodulated, Microcurrent and Diadynaniic modes of stimulation are all forms of transcutaneous electrical nerve stirnulation (TENS) or Interferential Current Therapy (IFC) available with the Solaris 709, 708, 706 & 705 and indicated for:
Symptomatic relief of chronic intractable pain and/or management of post traumatic or post-surgical pain
Ultrasound therapy is available with the Solaris 709 & 708 and indicated for:
Applying therapeutic deep heat within body tissues for the treatment of selected medical conditions suc!~as:
Relief of pain
Muscle spasms
Joint contractures
Infrared therapy is available as an optional accessory (D880) probe with the Solaris 709, 708, 706 & 705 and indicated 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/K031329 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031329: Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared Probe (Optional Accessory).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031329
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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