510(k) · Cleared
Recalled · 2005Dermosonic Non-Invasive Subdermal Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sybaritic, Inc. · IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Cleared on Jul 2, 2003 after a 190-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 11 later devices descend from it. It has been recalled once.
- Decided
- Jul 2, 2003
- Review
- 190 days
- Class
- Class II
- Product code
- IMI
- Recalls
- 1
- Predicates
- 0
11 later devices descend from it, 5 citing it directly.
- This deviceK024307 Dermosonic Non-Invasive Subdermal Therapy SystemSybaritic, Inc. · 2003
- Descendant · cites it directly · 4 of its ownK112520 US-101L, US-103SIto Co., Ltd. · 2011
- Descendant · 2 generations on · 3 of its ownK161628 JAS Pulse (TM) Ultrasonic TherapyBonutti Research, Inc. · 2016
- Descendant · cites it directly · 3 of its ownK053041 Med SculptGeneral Project S.R.L. · 2006
- Descendant · 3 generations on · 2 of its ownK241099 Plasonic (Plasonic)Hironic Co., Ltd. · 2024
- Descendant · cites it directly · 2 of its ownK091615 Med ContourGeneral Project S.R.L. · 2010
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K112520US-101L, US-103SIto Co., Ltd. · 2011 · cites it directly4descendants
- K161628JAS Pulse (TM) Ultrasonic TherapyBonutti Research, Inc. · 2016 · 2 generations on3descendants
- K053041Med SculptGeneral Project S.R.L. · 2006 · cites it directly3descendants
- K241099Plasonic (Plasonic)Hironic Co., Ltd. · 2024 · 3 generations on2descendants
- K091615Med ContourGeneral Project S.R.L. · 2010 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K024307 | Dermosonic Non-Invasive Subdermal Therapy System | Sybaritic, Inc. | 2003 | — |
| +1 | K112520 | US-101L, US-103S | Ito Co., Ltd. | 2011 | — |
| +2 | K161628 | JAS Pulse (TM) Ultrasonic Therapy | Bonutti Research, Inc. | 2016 | — |
| +1 | K053041 | Med Sculpt | General Project S.R.L. | 2006 | — |
| +3 | K241099 | Plasonic (Plasonic) | Hironic Co., Ltd. | 2024 | — |
| +1 | K091615 | Med Contour | General Project S.R.L. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2016 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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 10.3 · 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (11)
See all 115 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 5, 2005 | Not classified | Z-0578-05 | Other | Device is performing functions that are not cleared in the 510(k). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K112520 (Ito Co., Ltd., 2011) has gone furthest, with 4 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?
Indications for use include the following:
a. Therapeutic Massager:
1. Provides temporary relief of minor muscle aches and pains
11. Relieves muscle spasms
111. Temporarily improves local blood circulation
iv. Temporarily reduces the appearance of cellulite
b. Ultrasonic Diathermy:
i. Relief of pain
11. Muscle spasms
iii. Joint contractures
iv. NOT for the treatment of malignancies
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K024307 · printed Nov 6, 2026
Cite this page
510(k) Report. “K024307: Dermosonic Non-Invasive Subdermal Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024307
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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