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 Dec 11, 2013 as substantially equivalent to K121700 (Ulthera, Inc., 2012) and 1 other predicate after a 163-day review. Its family tree reaches back 2 generations to 1989. 16 later devices descend from it.
- Decided
- Dec 11, 2013
- Review
- 163 days
- Class
- Class II
- Product code
- OHV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K894834 (1989). 4 ancestors in all. 16 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK894834 Dermascan C, an Ultrasonic Diagnostic SystemBrymill Corp. · 1989
- 1 generation backK983945 Cortex Dermascan C Ultrasonic SystemCortex Technology Aps · 1999
- This deviceK132028 Ulthera SystemUlthera, Inc. · 2013
- Descendant · cites it directly · 15 of its ownK134032 Ulthera SystemUlthera, Inc. · 2014
- Descendant · 2 generations on · 13 of its ownK180623 Ulthera SystemUlthera, Inc. · 2018
- Descendant · 3 generations on · 8 of its ownK211483 SofWave SystemSofwave Medical, Ltd. · 2021
- Descendant · 4 generations on · 7 of its ownK223237 SofWave SystemSofwave Medical, Ltd. · 2022
- Descendant · 5 generations on · 6 of its ownK230019 SofWave SystemSofwave Medical, Ltd. · 2023
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K134032Ulthera SystemUlthera, Inc. · 2014 · cites it directly15descendants
- K180623Ulthera SystemUlthera, Inc. · 2018 · 2 generations on13descendants
- K211483SofWave SystemSofwave Medical, Ltd. · 2021 · 3 generations on8descendants
- K223237SofWave SystemSofwave Medical, Ltd. · 2022 · 4 generations on7descendants
- K230019SofWave SystemSofwave Medical, Ltd. · 2023 · 5 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K894834 | Dermascan C, an Ultrasonic Diagnostic System | Brymill Corp. | 1989 | — |
| −1 | K983945 | Cortex Dermascan C Ultrasonic System | Cortex Technology Aps | 1999 | — |
| 0 (this device) | K132028 | Ulthera System | Ulthera, Inc. | 2013 | — |
| +1 | K134032 | Ulthera System | Ulthera, Inc. | 2014 | — |
| +2 | K180623 | Ulthera System | Ulthera, Inc. | 2018 | — |
| +3 | K211483 | SofWave System | Sofwave Medical, Ltd. | 2021 | — |
| +4 | K223237 | SofWave System | Sofwave Medical, Ltd. | 2022 | — |
| +5 | K230019 | SofWave System | Sofwave Medical, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K121700 | Ulthera SystemSummary page 1…Iyo Legally Marketed Name: UltheraO System Predicates: 510(k): Ulthera, Inc., Ulthera System - K121700 Cortex Technology, DermaScan C- K(983945 Applicable Guidance: The Class I/ Special Controls Gu… | 2012 |
| * | K983945 | Cortex Dermascan C Ultrasonic SystemSummary page 1…ystem Predicates: 510(k): Ulthera, Inc., Ulthera System - K121700 Cortex Technology, DermaScan C- K(983945 Applicable Guidance: The Class I/ Special Controls Guidance Document: Focused Ultrasound Stimu… | 1999 |
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K134032 | Ulthera System | 2014 | 15 |
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 24 years and passes through 3 companies; a new generation was cleared every 14.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K134032 (Ulthera, Inc., 2014) has gone furthest, with 15 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. 2013, 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
The Ulthera System in conjunction with the Ulthera DeepSEE transducer allows for ultrasonic visualization of depths up to 8 mm below the surface of the skin. The indicated use of the imaging is to visualize the dermal and subdermal layers of tissue to:
ensure proper coupling of the transducer to the skin
confirm appropriate depth of treatment such as to avoid bone
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132028 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132028: 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/K132028
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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