ULTHERA SYSTEM, MODEL 8850-0001
FDA 510(k) clearance DEN080006 · decided 2009-09-11
Clearance details
- K-number
- DEN080006
- Device name
- ULTHERA SYSTEM, MODEL 8850-0001
- Applicant
- Ulthera, Inc.
- Decision
- Unknown
- Date received
- 2008-04-11
- Decision date
- 2009-09-11
- Days to decision
- 518 days
- Clearance type
- Post-NSE
- 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
+ Add to Predicate Builder ◉ Watch Ulthera
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 (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.