510(k) · Cleared
ClearedUlthera System (UC-1 Control Unit PRIME Model 2.1)
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 May 13, 2025 as substantially equivalent to K233996 (Ulthera, Inc., 2024) and 1 other predicate after an 89-day review. Its family tree reaches back 7 generations to 1989. 1 later device descends from it.
- Decided
- May 13, 2025
- Review
- 89 days
- Class
- Class II
- Product code
- OHV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K894834 (1989). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK894834 Dermascan C, an Ultrasonic Diagnostic SystemBrymill Corp. · 1989
- 6 generations backK983945 Cortex Dermascan C Ultrasonic SystemCortex Technology Aps · 1999
- 5 generations backK132028 Ulthera SystemUlthera, Inc. · 2013
- 4 generations backK134032 Ulthera SystemUlthera, Inc. · 2014
- 3 generations backK180623 Ulthera SystemUlthera, Inc. · 2018
- 2 generations backK233996 Ulthera System (UC-1 Control Unit PRIME)Ulthera, Inc. · 2024
- 1 generation backK243035 Ulthera® SystemUlthera, Inc. · 2025
- This deviceK250418 Ulthera System (UC-1 Control Unit PRIME Model 2.1)Ulthera, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK260618 Ulthera® SystemUlthera, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K260618Ulthera® SystemUlthera, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K894834 | Dermascan C, an Ultrasonic Diagnostic System | Brymill Corp. | 1989 | — |
| −6 | K983945 | Cortex Dermascan C Ultrasonic System | Cortex Technology Aps | 1999 | — |
| −5 | K132028 | Ulthera System | Ulthera, Inc. | 2013 | — |
| −4 | K134032 | Ulthera System | Ulthera, Inc. | 2014 | — |
| −3 | K180623 | Ulthera System | Ulthera, Inc. | 2018 | — |
| −2 | K233996 | Ulthera System (UC-1 Control Unit PRIME) | Ulthera, Inc. | 2024 | — |
| −1 | K243035 | Ulthera® System | Ulthera, Inc. | 2025 | — |
| 0 (this device) | K250418 | Ulthera System (UC-1 Control Unit PRIME Model 2.1) | Ulthera, Inc. | 2025 | — |
| +1 | K260618 | Ulthera® System | Ulthera, Inc. | 2026 | — |
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 |
|---|---|---|
| 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 K233996 Ulthera System (UC-1 Control Unit PRIME)score 14.1 · 5 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 |
|---|---|---|---|
| * | K233996 | Ulthera System (UC-1 Control Unit PRIME)Summary page 5…y System Considerations and Content of Premarket Submissions 3 PREDICATE DEVICE Ulthera System (UC-1 Control Unit PRIME), Ulthera, Inc., K233996 Ulthera System (UC-1 Control Unit PRIME), Ulthera, Inc., K243035… | 2024 |
| * | K243035 | Ulthera® System Cleared while this submission was under review Summary page 5…t of Premarket Submissions 3 PREDICATE DEVICE Ulthera System (UC-1 Control Unit PRIME), Ulthera, Inc., K233996 Ulthera System (UC-1 Control Unit PRIME), Ulthera, Inc., K243035 Page 1 of 6 Ulthe… | 2025 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260618 | Ulthera® System | 2026 | 0 |
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 36 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K260618 (Ulthera, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K233996.
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. 2025, 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 intended to apply focused ultrasound energy to the body to achieve temporary changes in the physical appearance of the skin. 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; which can also affect the appearance of lax tissue in the submental and neck regions • improve lines and wrinkles of the décolleté. •…
Read the full statement (154 words)
The Ulthera System is intended to apply focused ultrasound energy to the body to achieve temporary changes in the physical appearance of the skin.
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; which can also affect the appearance of lax tissue in the submental and neck regions
• improve lines and wrinkles of the décolleté.
• improve the appearance of skin laxity on the abdomen, anterior arms, and posterior arms.
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/K250418 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250418: Ulthera System (UC-1 Control Unit PRIME Model 2.1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250418
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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