510(k) · Cleared
ClearedMed Sculpt
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Project S.R.L. · IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Cleared on Aug 2, 2006 as substantially equivalent to K024307 (Sybaritic, Inc., 2003) after a 279-day review. Its family tree reaches back 1 generation to 2003. 3 later devices descend from it.
- Decided
- Aug 2, 2006
- Review
- 279 days
- Class
- Class II
- Product code
- IMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K024307 (2003). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK024307 Dermosonic Non-Invasive Subdermal Therapy SystemSybaritic, Inc. · 2003 · Recalled
- This deviceK053041 Med SculptGeneral Project S.R.L. · 2006
- Descendant · cites it directly · 2 of its ownK091615 Med ContourGeneral Project S.R.L. · 2010
- Descendant · 2 generations on · 0 of its ownK160075 Accent XLAlma Lasers, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK161502 MC1 PlusGeneral Project S.R.L. · 2016
Most influential descendants
Showing 3 of 3 · See allView 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) | K053041 | Med Sculpt | General Project S.R.L. | 2006 | — |
| +1 | K091615 | Med Contour | General Project S.R.L. | 2010 | — |
| +2 | K160075 | Accent XL | Alma Lasers, Inc. | 2016 | — |
| +2 | K161502 | MC1 Plus | General Project S.R.L. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2016 | 2 | 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? (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 1…The MED Sculpt Computerized Body Massager and M-Sonic Ultrasound Diathermy is substantially equivalent to the Dermosonic, manufactured by Sybaritic, Inc. (K024307). 4. Device Description The MED SCULPT Computerized Body Massager and M-Sonic Ultrasound Diathermy system has… | 2003 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091615 | Med Contour | 2010 | 2 |
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?
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 MED Sculpt Computerized Body Massager and M-Sonic Ultrasound Diathermy is indicated for:
a. Therapeutic Massager:
i. Provides temporary relief of minor muscle aches and pains
ii. Relieves muscle spasms
iii. Temporarily improves local blood circulation
iv. Temporarily reduces the appearance of cellulite
b. Ultrasonic Diathermy:
i. Relief of pain
ii. Muscle spasms
iii. Joint contractures
iv. NOT for the treatment of malignancies
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053041 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053041: Med Sculpt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053041
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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