510(k) · Cleared
ClearedContour I V3.1 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Syneron Medical, Ltd. · OHV Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
Cleared on Apr 10, 2014 as substantially equivalent to K112626 (Medicis Technologies Corporation, 2011) after a 171-day review. Its family tree reaches back 3 generations to 2009. 11 later devices descend from it.
- Decided
- Apr 10, 2014
- Review
- 171 days
- Class
- Class II
- Product code
- OHV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN080006 (2009). 11 later devices descend from it, 2 citing it directly.
- Root · 3 generations backDEN080006 Ulthera System, Model 8850-0001Ulthera, Inc. · 2009
- 2 generations backK100874 Liposonix System, Model 1 P00XXXXMedicis Technologies Corporation · 2011
- 1 generation backK112626 Lipsonix (R) System Model 2Medicis Technologies Corporation · 2011
- This deviceK133238 Contour I V3.1 SystemSyneron Medical, Ltd. · 2014
- Descendant · cites it directly · 10 of its ownK141708 Ultrashape SystemSyneron Medical, Ltd. · 2014
- Descendant · cites it directly · 6 of its ownK160896 Ultrashape Power SystemSyneron Medical, Ltd. · 2016
- Descendant · 2 generations on · 4 of its ownK191696 Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign…Cook Biotech Incorporated · 2019
- Descendant · 3 generations on · 3 of its ownK202430 Kerecis ReconstructKerecis Limited · 2021
- Descendant · 2 generations on · 1 of its ownK162163 UltraShape SystemSyneron Medical, Ltd. · 2016
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K141708Ultrashape SystemSyneron Medical, Ltd. · 2014 · cites it directly10descendants
- K160896Ultrashape Power SystemSyneron Medical, Ltd. · 2016 · cites it directly6descendants
- K191696Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix…Cook Biotech Incorporated · 2019 · 2 generations on4descendants
- K202430Kerecis ReconstructKerecis Limited · 2021 · 3 generations on3descendants
- K162163UltraShape SystemSyneron Medical, Ltd. · 2016 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN080006 | Ulthera System, Model 8850-0001 | Ulthera, Inc. | 2009 | — |
| −2 | K100874 | Liposonix System, Model 1 P00XXXX | Medicis Technologies Corporation | 2011 | — |
| −1 | K112626 | Lipsonix (R) System Model 2 | Medicis Technologies Corporation | 2011 | — |
| 0 (this device) | K133238 | Contour I V3.1 System | Syneron Medical, Ltd. | 2014 | — |
| +1 | K141708 | Ultrashape System | Syneron Medical, Ltd. | 2014 | — |
| +1 | K160896 | Ultrashape Power System | Syneron Medical, Ltd. | 2016 | — |
| +2 | K191696 | Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery… | Cook Biotech Incorporated | 2019 | — |
| +3 | K202430 | Kerecis Reconstruct | Kerecis Limited | 2021 | — |
| +2 | K162163 | UltraShape System | Syneron Medical, Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 3 | 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 OHV? 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 OHV device
- #1 K250418 Ulthera System (UC-1 Control Unit PRIME Model…score 14.1 · 7 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 |
|---|---|---|---|
| * | K112626 | Lipsonix (R) System Model 2Summary page 1…imulator System for Aesthetic Use 21 CFR 878.4590, Class 11,product code OHV Predicate Devices Medicis Technologies Corporation LipoSonix System Model 2 (K1 12626) Intended Use / Indications for Use The Contour I V3.1 System delivers focused ultrasound energy that can disrupt… | 2011 |
What descends from it? (11)
See all 112 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 5 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K141708 (Syneron Medical, Ltd., 2014) has gone furthest, with 10 descendants of its own.
- 2 other devices also cite its predicate K112626.
How does its category compare?
All OHV devicesOHV Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · OHV
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OHV
90in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OHV
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OHV
20in 2025
MAUDE reports naming product code OHV, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 18 |
| 2014 | 3 | 171 | 0 | 17 |
| 2015 | 0 | — | 0 | 19 |
| 2016 | 3 | 107 | 0 | 29 |
| 2017 | 1 | — | 0 | 29 |
| 2018 | 1 | — | 0 | 10 |
| 2019 | 2 | — | 0 | 15 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 1 | — | 0 | 11 |
| 2022 | 1 | — | 0 | 12 |
| 2023 | 7 | 90 | 1 | 11 |
| 2024 | 2 | — | 0 | 11 |
| 2025 | 2 | — | 0 | 20 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Contour I V3.1 System delivers focused ultrasound energy that can disrupt subcutaneous adipose tissue (SAT) to provide a non-invasive approach to achieve a desired aesthetic effect. It is intended for non-invasive reduction in abdominal circumference.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133238 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133238: Contour I V3.1 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133238
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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