510(k) · Cleared
ClearedUlthera System
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
Cleared on Oct 2, 2012 as substantially equivalent to DEN080006 (Ulthera, Inc., 2009) after a 117-day review. Its family tree reaches back 1 generation to 2009. 17 later devices descend from it.
- Decided
- Oct 2, 2012
- Review
- 117 days
- Class
- Class II
- Product code
- OHV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN080006 (2009). 17 later devices descend from it, 1 citing it directly.
- Root · 1 generation backDEN080006 Ulthera System, Model 8850-0001Ulthera, Inc. · 2009
- This deviceK121700 Ulthera SystemUlthera, Inc. · 2012
- Descendant · cites it directly · 16 of its ownK132028 Ulthera SystemUlthera, Inc. · 2013
- Descendant · 2 generations on · 15 of its ownK134032 Ulthera SystemUlthera, Inc. · 2014
- Descendant · 3 generations on · 13 of its ownK180623 Ulthera SystemUlthera, Inc. · 2018
- Descendant · 4 generations on · 8 of its ownK211483 SofWave SystemSofwave Medical, Ltd. · 2021
- Descendant · 5 generations on · 7 of its ownK223237 SofWave SystemSofwave Medical, Ltd. · 2022
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K132028Ulthera SystemUlthera, Inc. · 2013 · cites it directly16descendants
- K134032Ulthera SystemUlthera, Inc. · 2014 · 2 generations on15descendants
- K180623Ulthera SystemUlthera, Inc. · 2018 · 3 generations on13descendants
- K211483SofWave SystemSofwave Medical, Ltd. · 2021 · 4 generations on8descendants
- K223237SofWave SystemSofwave Medical, Ltd. · 2022 · 5 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN080006 | Ulthera System, Model 8850-0001 | Ulthera, Inc. | 2009 | — |
| 0 (this device) | K121700 | Ulthera System | Ulthera, Inc. | 2012 | — |
| +1 | K132028 | Ulthera System | Ulthera, Inc. | 2013 | — |
| +2 | K134032 | Ulthera System | Ulthera, Inc. | 2014 | — |
| +3 | K180623 | Ulthera System | Ulthera, Inc. | 2018 | — |
| +4 | K211483 | SofWave System | Sofwave Medical, Ltd. | 2021 | — |
| +5 | K223237 | SofWave System | Sofwave Medical, Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 1 | 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 |
|---|---|---|---|
| * | DEN080006 | Ulthera System, Model 8850-0001 Our reading of the summary gave K072505, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN080006, Ulthera System, Model 8850-0001 (Ulthera, Inc.), granted Sep 11, 2009; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2009 |
What descends from it? (17)
See all 171 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132028 | Ulthera System | 2013 | 16 |
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?
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. 2012, 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 Ulthera@ System is indicated for use as a non-invasive dermatological aesthetic treatment to:
lift the eyebrow
lift lax submental (beneath the chin) and neck tissue
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121700 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121700: Ulthera System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121700
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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