510(k) K240687
- Device
- SofWave System
- Applicant
- Sofwave Medical, Ltd.
- 510(k) number
- K240687
- Product code
- OHV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-05-30
- Date received
- 2024-03-12
- Regulation
- 878.4590
- Classification name
- Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Ruthie Amir
- Address
- 1 Ha-Otsma St. Yokneam Iiit IL 2069200 2069200
FDA Registration Numbers#
- 3005646850
- 3015889734
- 1012187
- 3006985163
- 3012259264
- 1725006
- 3009736547
- 3013917867
- 3013840437
- 3027725665
- 3011423170
- 1313525
- 2030624
- 2133641
- 3033715699
Source Documents#
Other 510(k) Records For Product Code OHV#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260618 | Ulthera® System | Ulthera, Inc. | 2026-05-21 |
| K250418 | Ulthera System (UC-1 Control Unit PRIME Model 2.1) | Ulthera, Inc. | 2025-05-13 |
| K243035 | Ulthera® System | Ulthera, Inc. | 2025-02-24 |
| K233996 | Ulthera System (UC-1 Control Unit PRIME) | Ulthera, Inc. | 2024-02-22 |
| K233104 | SofWave System | Sofwave Medical, Ltd. | 2023-12-22 |
| K232455 | SofWave System | Sofwave Medical, Ltd. | 2023-12-14 |
| K230100 | SCIZER (SC1-M410) | Classys, Inc. | 2023-11-03 |
| K231628 | BeShape One™ Device | Beshape Technologies , Ltd. | 2023-09-29 |
| K231537 | SofWave System | Sofwave Medical, Ltd. | 2023-08-28 |
| K230820 | SofWave System | Sofwave Medical, Ltd. | 2023-04-18 |
| K230019 | SofWave System | Sofwave Medical, Ltd. | 2023-03-14 |
| K223237 | SofWave System | Sofwave Medical, Ltd. | 2022-12-16 |
| K211483 | SofWave System | Sofwave Medical, Ltd. | 2021-11-15 |
| K181896 | LIPOcel | Jeisys Medical, Inc. | 2019-10-18 |
| K191421 | Sofacia System | Sofwave Medical, Ltd. | 2019-09-09 |