510(k) · Cleared
ClearedDermosonic Non-Invasive Subdermal Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
S.O.R. Internacional, S.A. · IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Cleared on Jun 12, 2006 as substantially equivalent to K024307 (Sybaritic, Inc., 2003) after a 236-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Jun 12, 2006
- Review
- 236 days
- Class
- Class II
- Product code
- IMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K024307 (2003). No later device cites it as a predicate yet.
- Root · 1 generation backK024307 Dermosonic Non-Invasive Subdermal Therapy SystemSybaritic, Inc. · 2003 · Recalled
- This deviceK052934 Dermosonic Non-Invasive Subdermal Therapy SystemS.O.R. Internacional, S.A. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K024307 | Dermosonic Non-Invasive Subdermal Therapy System | Sybaritic, Inc. | 2003 | 1 |
| 0 (this device) | K052934 | Dermosonic Non-Invasive Subdermal Therapy System | S.O.R. Internacional, S.A. | 2006 | — |
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? (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 |
|---|---|---|---|
| * | K024307 | Dermosonic Non-Invasive Subdermal Therapy SystemSummary page 2…n this submission is: Sybaritic, Inc. Dermosonic Non- Invasive Subdermal Therapy System 510(k) K024307 Safety and Effectiveness: Safety and performance testing has been completed on the S.O.R. Internacional, S.A. Dermosonic. The S… | 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?
- Its one ancestor has a recall.
- 4 other devices also cite its predicate K024307.
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?
The indications for use include the following:
a. Therapeutic Massager:
Provides temporary relief of minor muscle aches and pains;
Relieves muscle spasms;
Temporarily improves local blood circulation;
Temporarily reduces the appearance of cellulite.
b. Ultrasonic Diathermy:
Relief of pain;
Muscle spasms;
Joint contractures;
NOT for the treatment of malignancies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052934 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052934: Dermosonic Non-Invasive Subdermal Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052934
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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