Identity
- Trade Name
- Ulthera System Control Unit FDA UDI
- Generic Name
- Ultrasonic skin/body contouring system FDA UDI
- Model / Reference
- UC-1 Rev. L FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840763100254 FDA UDI
- 510(k) Number
- K134032 FDA UDI
- FDA Product Code
- OHV FDA UDIIYO FDA UDI
- GMDN Term
- Ultrasonic skin/body contouring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4590 FDA UDI892.1560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ultrasonic skin/body contouring system
Ulthera System Control Unit by Ulthera Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K134032 also covers:
- Ulthera System Control Unit — Ulthera Inc
- Ulthera System Control Unit — Ulthera Inc
- Ulthera System Control Unit — Ulthera Inc
- Ulthera System Control Unit — Ulthera Inc
- Ulthera System Control Unit — Ulthera Inc
- Ulthera System Handpiece — Ulthera Inc
- Ulthera System Handpiece — Ulthera Inc
- Ulthera System Handpiece — Ulthera Inc
- Ulthera System Handpiece — Ulthera Inc
- Ulthera System Handpiece — Ulthera Inc
- Ulthera System Handpiece — Ulthera Inc
- Ulthera System Transducer — Ulthera Inc
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ulthera Inc
Sources (1)
- FDA UDI 0fd748bc-7bc5-409b-9aaa-2dccda948b01 33 fields · synced May 30, 2026