ULTHERA SYSTEM
FDA 510(k) clearance K132028 · decided 2013-12-11
Clearance details
- K-number
- K132028
- Device name
- ULTHERA SYSTEM
- Applicant
- Ulthera, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-07-01
- Decision date
- 2013-12-11
- Days to decision
- 163 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
- Mesa, AZ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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| Record | Firm | Date |
|---|---|---|
| Ulthera® System (K260618) | Ulthera, Inc. | 2026-05-21 |
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| Ulthera® System (K243035) | Ulthera, Inc. | 2025-02-24 |
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| Ulthera System (UC-1 Control Unit PRIME) (K233996) | Ulthera, Inc. | 2024-02-22 |
| SofWave System (K233104) | Sofwave Medical, Ltd. | 2023-12-22 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.