FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
SofWave System
K Number: K232455
·
Decision Dec 14, 2023
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
29
Applicant Total
12
Review Days
122
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Basic Information
- Device Name
- SofWave System
- K Number
- K232455
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4590
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sofwave Medical, Ltd.
- Date Received
- August 14, 2023
- Decision Date
- December 14, 2023
- Product Code
- OHV
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- PM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OHV | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OHV), ordered by most recent decision date.
Ulthera® System
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Ulthera System (UC-1 Control Unit PRIME Model 2.1)
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Ulthera® System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SofWave System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Ulthera System (UC-1 Control Unit PRIME)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SofWave System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Sofwave Medical, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K251746 | Pure Impact | Jul 2, 2025 | Substantially Equivalent |
| K250146 | SofWave System | Apr 18, 2025 | Substantially Equivalent |
| K241685 | SofWave System | Aug 7, 2024 | Substantially Equivalent |
| K240687 | SofWave System | May 30, 2024 | Substantially Equivalent |
| K233104 | SofWave System | Dec 22, 2023 | Substantially Equivalent |
| K231537 | SofWave System | Aug 28, 2023 | Substantially Equivalent |
| K230820 | SofWave System | Apr 18, 2023 | Substantially Equivalent |
| K230019 | SofWave System | Mar 14, 2023 | Substantially Equivalent |
| K223237 | SofWave System | Dec 16, 2022 | Substantially Equivalent |
| K211483 | SofWave System | Nov 15, 2021 | Substantially Equivalent |