Sofwave Medical, Ltd.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Sofwave Medical, Ltd.” (first 2019, latest 2025), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 83 days. Since 2017 the median was 83 days, against 130 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 1 | 104 |
| 2020 | 0 | — |
| 2021 | 1 | 187 |
| 2022 | 1 | 58 |
| 2023 | 5 | 87 |
| 2024 | 2 | 68 |
| 2025 | 2 | 56 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Sofwave Medical, Ltd. took a median 83 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 130 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OHV | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption | 9 | 9 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 3 | 3 |
Review panels
Most recent Sofwave Medical, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251746 | Pure Impact | NGX | 2025-07-02 | 26 |
| K250146 | SofWave System | NGX | 2025-04-18 | 87 |
| K241685 | SofWave System | NGX | 2024-08-07 | 57 |
| K240687 | SofWave System | OHV | 2024-05-30 | 79 |
| K233104 | SofWave System | OHV | 2023-12-22 | 87 |
| K232455 | SofWave System | OHV | 2023-12-14 | 122 |
| K231537 | SofWave System | OHV | 2023-08-28 | 90 |
| K230820 | SofWave System | OHV | 2023-04-18 | 25 |
| K230019 | SofWave System | OHV | 2023-03-14 | 70 |
| K223237 | SofWave System | OHV | 2022-12-16 | 58 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sofwave Medical, Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Sofwave Medical, Ltd. is the lead sponsor of 11 device studies on ClinicalTrials.gov (3 active or recruiting). Most recent:
- NCT07094971: Pure Impact Treatment to Strengthen and Tone Abdomen, Quadriceps and Glutes Muscles (Recruiting, started 2025-07-11)
- NCT06724146: Combined Treatment Sofwave and Pure Impact to Strength and Tone Muscles and Improve Lax Skin Appearance (Active not recruiting, started 2024-08-05)
- NCT06333067: Treatment to Lift Facial Lax Skin and Improve Facial Wrinkles Using Precise and Lift Applicators (Recruiting, started 2023-10-11)
- NCT06104514: Safety and Efficacy of SofWave Treatment to Lift the Upper Lip and Improve the Peri-Oral Rhytids (Completed, started 2023-07-01)
- NCT05882721: Treatment for Improvement of Cellulite Appearance Using Form Applicator (Completed, started 2023-02-20)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sofwave Medical, Ltd.?
FDA lists 12 510(k) clearances under the applicant name “Sofwave Medical, Ltd.” (first 2019, latest 2025), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Sofwave Medical, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sofwave Medical, Ltd. is 83 days. Since 2017: 83 days, versus 130 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Sofwave Medical, Ltd.?
The most frequent FDA product codes under this applicant name are OHV (Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption, 9); NGX (Stimulator, Muscle, Powered, For Muscle Conditioning, 3).
Next steps
- See all 12 Sofwave Medical, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code OHV, Sofwave Medical, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.