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 Aug 28, 2023 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Aug 28, 2023
- Review
- 90 days
- Class
- Class II
- Product code
- OHV
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK231537 SofWave SystemSofwave Medical, Ltd. · 2023
- Descendant · cites it directly · 2 of its ownK233104 SofWave SystemSofwave Medical, Ltd. · 2023
- Descendant · 2 generations on · 1 of its ownK250146 SofWave SystemSofwave Medical, Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK251746 Pure ImpactSofwave Medical, Ltd. · 2025
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K231537 | SofWave System | Sofwave Medical, Ltd. | 2023 | — |
| +1 | K233104 | SofWave System | Sofwave Medical, Ltd. | 2023 | — |
| +2 | K250146 | SofWave System | Sofwave Medical, Ltd. | 2025 | — |
| +3 | K251746 | Pure Impact | Sofwave Medical, Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) 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
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233104 | SofWave System | 2023 | 2 |
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, K233104 (Sofwave Medical, Ltd., 2023) has gone furthest, with 2 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. 2023, 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/K231537 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231537: 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/K231537
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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