De Novo · Granted
GrantedUlthera System, Model 8850-0001
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ulthera, Inc. · OHV Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
Granted on Sep 11, 2009 as a new device type through De Novo after a 518-day review. 36 later devices descend from it.
- Decided
- Sep 11, 2009
- Review
- 518 days
- Class
- Class II
- Product code
- OHV
- Recalls
- None
36 later devices descend from it, 3 citing it directly.
- This deviceDEN080006 Ulthera System, Model 8850-0001Ulthera, Inc. · 2009
- Descendant · cites it directly · 17 of its ownK121700 Ulthera SystemUlthera, Inc. · 2012
- Descendant · 2 generations on · 16 of its ownK132028 Ulthera SystemUlthera, Inc. · 2013
- Descendant · cites it directly · 16 of its ownK100874 Liposonix System, Model 1 P00XXXXMedicis Technologies Corporation · 2011
- Descendant · 3 generations on · 15 of its ownK134032 Ulthera SystemUlthera, Inc. · 2014
- Descendant · 2 generations on · 15 of its ownK112626 Lipsonix (R) System Model 2Medicis Technologies Corporation · 2011
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K121700Ulthera SystemUlthera, Inc. · 2012 · cites it directly17descendants
- K132028Ulthera SystemUlthera, Inc. · 2013 · 2 generations on16descendants
- K100874Liposonix System, Model 1 P00XXXXMedicis Technologies Corporation · 2011 · cites it directly16descendants
- K134032Ulthera SystemUlthera, Inc. · 2014 · 3 generations on15descendants
- K112626Lipsonix (R) System Model 2Medicis Technologies Corporation · 2011 · 2 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN080006 | Ulthera System, Model 8850-0001 | Ulthera, Inc. | 2009 | — |
| +1 | K121700 | Ulthera System | Ulthera, Inc. | 2012 | — |
| +2 | K132028 | Ulthera System | Ulthera, Inc. | 2013 | — |
| +1 | K100874 | Liposonix System, Model 1 P00XXXX | Medicis Technologies Corporation | 2011 | — |
| +3 | K134032 | Ulthera System | Ulthera, Inc. | 2014 | — |
| +2 | K112626 | Lipsonix (R) System Model 2 | Medicis Technologies Corporation | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 5 | 0 |
| 2024 | 3 | 0 |
| 2025 | 7 | 0 |
| 2026 | 1 | 0 |
Sources: FDA De Novo database (decision fields), 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (36)
See all 363 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?
- Of its descendants, K121700 (Ulthera, Inc., 2012) has gone furthest, with 17 descendants of its own.
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. 2009, 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 | — |
https://510kreport.com/device/DEN080006 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN080006: Ulthera System, Model 8850-0001.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN080006
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026