510(k) · Cleared
ClearedUltrashape Power 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 May 15, 2017 as substantially equivalent to K162163 (Syneron Medical, Ltd., 2016) and 2 other predicates after a 98-day review. Its family tree reaches back 6 generations to 2009.
- Decided
- May 15, 2017
- Review
- 98 days
- Class
- Class II
- Product code
- OHV
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to DEN080006 (2009). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backDEN080006 Ulthera System, Model 8850-0001Ulthera, Inc. · 2009
- 5 generations backK100874 Liposonix System, Model 1 P00XXXXMedicis Technologies Corporation · 2011
- 4 generations backK112626 Lipsonix (R) System Model 2Medicis Technologies Corporation · 2011
- 3 generations backK133238 Contour I V3.1 SystemSyneron Medical, Ltd. · 2014
- 2 generations backK141708 Ultrashape SystemSyneron Medical, Ltd. · 2014
- 1 generation backK160896 Ultrashape Power SystemSyneron Medical, Ltd. · 2016
- This deviceK170370 Ultrashape Power SystemSyneron Medical, Ltd. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | DEN080006 | Ulthera System, Model 8850-0001 | Ulthera, Inc. | 2009 | — |
| −5 | K100874 | Liposonix System, Model 1 P00XXXX | Medicis Technologies Corporation | 2011 | — |
| −4 | K112626 | Lipsonix (R) System Model 2 | Medicis Technologies Corporation | 2011 | — |
| −3 | K133238 | Contour I V3.1 System | Syneron Medical, Ltd. | 2014 | — |
| −2 | K141708 | Ultrashape System | Syneron Medical, Ltd. | 2014 | — |
| −1 | K160896 | Ultrashape Power System | Syneron Medical, Ltd. | 2016 | — |
| 0 (this device) | K170370 | Ultrashape Power System | Syneron Medical, Ltd. | 2017 | — |
Other ancestors 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 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? (3)
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 |
|---|---|---|---|
| * | K162163 | UltraShape SystemSummary page 4…Ultrasound Stimulator System for Aesthetic Use Classification 21 CFR 878.4590, Class II, product code OHV Predicate Devices Syneron UltraShape System (K162163, K161952) (Primary Predicate) Syneron UltraShape Power System (K160896) Intended Use / Indications for Use The U… | 2016 |
| * | K161952 | UltraShape SystemSummary page 4…nd Stimulator System for Aesthetic Use Classification 21 CFR 878.4590, Class II, product code OHV Predicate Devices Syneron UltraShape System (K162163, K161952) (Primary Predicate) Syneron UltraShape Power System (K160896) Intended Use / Indications for Use The UltraShape… | 2016 |
| * | K160896 | Ultrashape Power SystemSummary page 4…878.4590, Class II, product code OHV Predicate Devices Syneron UltraShape System (K162163, K161952) (Primary Predicate) Syneron UltraShape Power System (K160896) Intended Use / Indications for Use The UltraShape Power System delivers focused ultrasound energy that can disrupt subc… | 2016 |
| † | K133238 | Contour I V3.1 System | 2014 |
| † | K150230 | SculpSure | 2015 |
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?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- None of the 8 ancestors has a recall.
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. 2017, 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 UltraShape Power System delivers focused ultrasound energy that can disrupt subcutaneous adipose tissue (SAT) for lipolysis (breakdown of fat) to provide a non-invasive approach to achieve a desired aesthetic effect. It is intended for non-invasive reduction in abdominal circumference and fat reduction in the flanks and thighs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170370 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170370: Ultrashape Power System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170370
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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