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 Jul 8, 2016 as substantially equivalent to K141708 (Syneron Medical, Ltd., 2014) and 1 other predicate after a 99-day review. Its family tree reaches back 5 generations to 2009. 6 later devices descend from it.
- Decided
- Jul 8, 2016
- Review
- 99 days
- Class
- Class II
- Product code
- OHV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to DEN080006 (2009). 6 later devices descend from it, 2 citing it directly.
- Root · 5 generations backDEN080006 Ulthera System, Model 8850-0001Ulthera, Inc. · 2009
- 4 generations backK100874 Liposonix System, Model 1 P00XXXXMedicis Technologies Corporation · 2011
- 3 generations backK112626 Lipsonix (R) System Model 2Medicis Technologies Corporation · 2011
- 2 generations backK133238 Contour I V3.1 SystemSyneron Medical, Ltd. · 2014
- 1 generation backK141708 Ultrashape SystemSyneron Medical, Ltd. · 2014
- This deviceK160896 Ultrashape Power SystemSyneron Medical, Ltd. · 2016
- Descendant · cites it directly · 4 of its ownK191696 Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign…Cook Biotech Incorporated · 2019
- Descendant · 2 generations on · 3 of its ownK202430 Kerecis ReconstructKerecis Limited · 2021
- Descendant · 3 generations on · 0 of its ownK251844 Kerecis SurgiBind (50241)Kerecis Limited · 2025
- Descendant · 3 generations on · 0 of its ownK251224 Restrata Soft Tissue Reinforcement (STR)Acera Surgical, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK243843 Tendon Protect (50242)Kerecis Limited · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K191696Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix…Cook Biotech Incorporated · 2019 · cites it directly4descendants
- K202430Kerecis ReconstructKerecis Limited · 2021 · 2 generations on3descendants
- K251844Kerecis SurgiBind (50241)Kerecis Limited · 2025 · 3 generations on0descendants
- K251224Restrata Soft Tissue Reinforcement (STR)Acera Surgical, Inc. · 2025 · 3 generations on0descendants
- K243843Tendon Protect (50242)Kerecis Limited · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN080006 | Ulthera System, Model 8850-0001 | Ulthera, Inc. | 2009 | — |
| −4 | K100874 | Liposonix System, Model 1 P00XXXX | Medicis Technologies Corporation | 2011 | — |
| −3 | K112626 | Lipsonix (R) System Model 2 | Medicis Technologies Corporation | 2011 | — |
| −2 | K133238 | Contour I V3.1 System | Syneron Medical, Ltd. | 2014 | — |
| −1 | K141708 | Ultrashape System | Syneron Medical, Ltd. | 2014 | — |
| 0 (this device) | K160896 | Ultrashape Power System | Syneron Medical, Ltd. | 2016 | — |
| +1 | K191696 | Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery… | Cook Biotech Incorporated | 2019 | — |
| +2 | K202430 | Kerecis Reconstruct | Kerecis Limited | 2021 | — |
| +3 | K251844 | Kerecis SurgiBind (50241) | Kerecis Limited | 2025 | — |
| +3 | K251224 | Restrata Soft Tissue Reinforcement (STR) | Acera Surgical, Inc. | 2025 | — |
| +3 | K243843 | Tendon Protect (50242) | Kerecis Limited | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 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? (2)
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 |
|---|---|---|---|
| * | K141708 | Ultrashape SystemSummary page 4…und Stimulator System for Aesthetic Use Classification 21 CFR 878.4590, Class II, product code OHV Predicate Devices Syneron Medical Ltd.’s UltraShape (K141708) Syneron Medical Ltd.’s Contour I V3.1 (K133238) Intended Use / Indications for Use The UltraShape Power System d… | 2014 |
| * | K133238 | Contour I V3.1 SystemSummary page 4…21 CFR 878.4590, Class II, product code OHV Predicate Devices Syneron Medical Ltd.’s UltraShape (K141708) Syneron Medical Ltd.’s Contour I V3.1 (K133238) Intended Use / Indications for Use The UltraShape Power System delivers focused ultrasound energy that can disrupt… | 2014 |
What descends from it? (6)
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 3 companies; a new generation was cleared every 1.8 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K191696 (Cook Biotech Incorporated, 2019) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K141708.
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. 2016, 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) 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/K160896 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160896: Ultrashape Power System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160896
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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