510(k) · Cleared
ClearedSofWave System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sofwave Medical, Ltd. · OHV Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
Cleared on Nov 15, 2021 as substantially equivalent to K180623 (Ulthera, Inc., 2018) after a 187-day review. Its family tree reaches back 5 generations to 1989. 8 later devices descend from it.
- Decided
- Nov 15, 2021
- Review
- 187 days
- Class
- Class II
- Product code
- OHV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K894834 (1989). 7 ancestors in all. 8 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK894834 Dermascan C, an Ultrasonic Diagnostic SystemBrymill Corp. · 1989
- 4 generations backK983945 Cortex Dermascan C Ultrasonic SystemCortex Technology Aps · 1999
- 3 generations backK132028 Ulthera SystemUlthera, Inc. · 2013
- 2 generations backK134032 Ulthera SystemUlthera, Inc. · 2014
- 1 generation backK180623 Ulthera SystemUlthera, Inc. · 2018
- This deviceK211483 SofWave SystemSofwave Medical, Ltd. · 2021
- Descendant · cites it directly · 7 of its ownK223237 SofWave SystemSofwave Medical, Ltd. · 2022
- Descendant · 2 generations on · 6 of its ownK230019 SofWave SystemSofwave Medical, Ltd. · 2023
- Descendant · 3 generations on · 5 of its ownK230820 SofWave SystemSofwave Medical, Ltd. · 2023
- Descendant · 4 generations on · 4 of its ownK232455 SofWave SystemSofwave Medical, Ltd. · 2023
- Descendant · 5 generations on · 3 of its ownK240687 SofWave SystemSofwave Medical, Ltd. · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K223237SofWave SystemSofwave Medical, Ltd. · 2022 · cites it directly7descendants
- K230019SofWave SystemSofwave Medical, Ltd. · 2023 · 2 generations on6descendants
- K230820SofWave SystemSofwave Medical, Ltd. · 2023 · 3 generations on5descendants
- K232455SofWave SystemSofwave Medical, Ltd. · 2023 · 4 generations on4descendants
- K240687SofWave SystemSofwave Medical, Ltd. · 2024 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K894834 | Dermascan C, an Ultrasonic Diagnostic System | Brymill Corp. | 1989 | — |
| −4 | K983945 | Cortex Dermascan C Ultrasonic System | Cortex Technology Aps | 1999 | — |
| −3 | K132028 | Ulthera System | Ulthera, Inc. | 2013 | — |
| −2 | K134032 | Ulthera System | Ulthera, Inc. | 2014 | — |
| −1 | K180623 | Ulthera System | Ulthera, Inc. | 2018 | — |
| 0 (this device) | K211483 | SofWave System | Sofwave Medical, Ltd. | 2021 | — |
| +1 | K223237 | SofWave System | Sofwave Medical, Ltd. | 2022 | — |
| +2 | K230019 | SofWave System | Sofwave Medical, Ltd. | 2023 | — |
| +3 | K230820 | SofWave System | Sofwave Medical, Ltd. | 2023 | — |
| +4 | K232455 | SofWave System | Sofwave Medical, Ltd. | 2023 | — |
| +5 | K240687 | SofWave System | Sofwave Medical, Ltd. | 2024 | — |
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 |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K180623 | Ulthera SystemSummary page 4…FR 878.4590 (Ultrasound for Tissue Heat or Mechanical Cellular Disruption), Class II, product code OHV Predicate Devices Ulthera, Inc.’s Ulthera® System (K180623) (Predicate device) Sofwave Medical’s Sofacia System (K191421) (Reference device) Indications for Use The SofWav… | 2018 |
| † | K191421 | Sofacia System | 2019 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223237 | SofWave System | 2022 | 7 |
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 32 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K223237 (Sofwave Medical, Ltd., 2022) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K180623.
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. 2021, 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 SofWave System is indicated for use as a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles, lift the eyebrow, and lift lax submental (beneath the chin) and neck tissue; which can also affect the appearance of lax tissue in the submental and neck regions for subjects aged 22 and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211483 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211483: SofWave System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211483
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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