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 Dec 22, 2023 as substantially equivalent to K231537 (Sofwave Medical, Ltd., 2023) after an 87-day review. Its family tree reaches back 1 generation to 2023. 2 later devices descend from it.
- Decided
- Dec 22, 2023
- Review
- 87 days
- Class
- Class II
- Product code
- OHV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K231537 (2023). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK231537 SofWave SystemSofwave Medical, Ltd. · 2023
- This deviceK233104 SofWave SystemSofwave Medical, Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK250146 SofWave SystemSofwave Medical, Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK251746 Pure ImpactSofwave Medical, Ltd. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K231537 | SofWave System | Sofwave Medical, Ltd. | 2023 | — |
| 0 (this device) | K233104 | SofWave System | Sofwave Medical, Ltd. | 2023 | — |
| +1 | K250146 | SofWave System | Sofwave Medical, Ltd. | 2025 | — |
| +2 | K251746 | Pure Impact | Sofwave Medical, Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K231537 | SofWave SystemSummary page 5…Name 21 CFR 878.4590 (Focused Ultrasound Stimulator System for Aesthetic Use), Class II, product code OHV Predicate Device SofWave Medical’s SofWave System (K231537) Technological Characteristics The SofWave System is an ultrasound system intended for aesthetic purposes. The system gen… | 2023 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250146 | SofWave System | 2025 | 1 |
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?
- Its one ancestor has no recall.
- Of its descendants, K250146 (Sofwave Medical, Ltd., 2025) has gone furthest, with 1 descendant 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 | — |
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. The SofWave System is also intended for short-term improvement in the appearance of cellulite and the treatment of acne scars. The SofWave System is indicated to improve the appearance of skin laxity on the upper arms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233104 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233104: 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/K233104
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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