510(k) · Cleared
ClearedMed Contour
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 May 6, 2010 as substantially equivalent to K053041 (General Project S.R.L., 2006) and 3 other predicates after a 337-day review. Its family tree reaches back 2 generations to 2003. 2 later devices descend from it.
- Decided
- May 6, 2010
- Review
- 337 days
- Class
- Class II
- Product code
- IMI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K024307 (2003). 4 ancestors in all, the oldest K883893 (1988). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK024307 Dermosonic Non-Invasive Subdermal Therapy SystemSybaritic, Inc. · 2003 · Recalled
- 1 generation backK053041 Med SculptGeneral Project S.R.L. · 2006
- This deviceK091615 Med ContourGeneral Project S.R.L. · 2010
- Descendant · cites it directly · 0 of its ownK160075 Accent XLAlma Lasers, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK161502 MC1 PlusGeneral Project S.R.L. · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K024307 | Dermosonic Non-Invasive Subdermal Therapy System | Sybaritic, Inc. | 2003 | 1 |
| −1 | K053041 | Med Sculpt | General Project S.R.L. | 2006 | — |
| 0 (this device) | K091615 | Med Contour | General Project S.R.L. | 2010 | — |
| +1 | K160075 | Accent XL | Alma Lasers, Inc. | 2016 | — |
| +1 | K161502 | MC1 Plus | General Project S.R.L. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K053041 | Med SculptSummary page 1…(21 CFR 890.5300) 3. Legally Marketed Predicate Devices The MCi is substantially equivalent to the following devices: MED Sculpt, manufactured by General Project (K053041), Dermosonic, manufactured by Sybaritic, Inc. (K024307), Forte CPS 400 Combo (K982830), manufactured by Chattanooga Group,… | 2006 |
| * | K024307 | Dermosonic Non-Invasive Subdermal Therapy SystemSummary page 1…The MCi is substantially equivalent to the following devices: MED Sculpt, manufactured by General Project (K053041), Dermosonic, manufactured by Sybaritic, Inc. (K024307), Forte CPS 400 Combo (K982830), manufactured by Chattanooga Group, Inc. and Omnisound 3000 (K883893), manufactured by Physic… | 2003 |
| * | K982830 | Forte, Models CPS 400 Combo, CPS 200 ComboSummary page 1…valent to the following devices: MED Sculpt, manufactured by General Project (K053041), Dermosonic, manufactured by Sybaritic, Inc. (K024307), Forte CPS 400 Combo (K982830), manufactured by Chattanooga Group, Inc. and Omnisound 3000 (K883893), manufactured by Physic Technology, Inc. === Page 2… | 1998 |
| * | K883893 | Omnisound (TM) 3000Summary page 1…roject (K053041), Dermosonic, manufactured by Sybaritic, Inc. (K024307), Forte CPS 400 Combo (K982830), manufactured by Chattanooga Group, Inc. and Omnisound 3000 (K883893), manufactured by Physic Technology, Inc. 4. Device Description The MCi is a computerized body massager and ul… | 1988 |
What descends from it? (2)
2 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)
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 7 years and passes through 2 companies; a new generation was cleared every 3.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K160075 (Alma Lasers, Inc., 2016) has gone furthest, with 0 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. 2010, this device’s year, is highlighted.
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 MCi is indicated for:
a) Therapeutic Massager:
1. Provides temporary relief of minor muscle aches and pains;
2. Relieves muscle spasms,
3. Temporarily improves local blood circulation;
4. Temporarily reduces the appearance of cellulite.
b) Ultrasonic Diathermy:
1. Relief of pain;
2. Muscle spasms;
3. Joint contractures;
4. NOT for the treatment of malignancies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091615 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091615: Med Contour.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091615
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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