SofWave System
FDA 510(k) clearance K233104 · decided 2023-12-22
Clearance details
- K-number
- K233104
- Device name
- SofWave System
- Applicant
- Sofwave Medical, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-09-26
- Decision date
- 2023-12-22
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- OHV
- Device class
- 2
- Regulation number
- 878.4590
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Yokneam Iiit, IL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Ulthera® System (K260618) | Ulthera, Inc. | 2026-05-21 |
| Ulthera System (UC-1 Control Unit PRIME Model 2.1) (K250418) | Ulthera, Inc. | 2025-05-13 |
| Ulthera® System (K243035) | Ulthera, Inc. | 2025-02-24 |
| SofWave System (K240687) | Sofwave Medical, Ltd. | 2024-05-30 |
| Ulthera System (UC-1 Control Unit PRIME) (K233996) | Ulthera, Inc. | 2024-02-22 |
| SofWave System (K232455) | Sofwave Medical, Ltd. | 2023-12-14 |
| SCIZER (SC1-M410) (K230100) | Classys, Inc. | 2023-11-03 |
| BeShape One™ Device (K231628) | Beshape Technologies , Ltd. | 2023-09-29 |
| SofWave System (K231537) | Sofwave Medical, Ltd. | 2023-08-28 |
| SofWave System (K230820) | Sofwave Medical, Ltd. | 2023-04-18 |
| SofWave System (K230019) | Sofwave Medical, Ltd. | 2023-03-14 |
| SofWave System (K223237) | Sofwave Medical, Ltd. | 2022-12-16 |
Recalls involving this device
No recalls on record reference this clearance.