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Ulthera System Transducer
FDA UDIFDA 510(k)Class II (US FDA UDI)
510(k) K260618
by Ulthera Inc
Identity
- Trade Name
- Ulthera System Transducer FDA UDI
- Generic Name
- Ultrasound hyperthermia system transducer, extracorporeal FDA UDI
- Model / Reference
- UT-4 Rev. G FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840763100346 FDA UDI
- 510(k) Number
- K134032 FDA UDI
- FDA Product Code
- IYO FDA UDIOHV FDA UDI
- GMDN Term
- Ultrasound hyperthermia system transducer, extracorporeal FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1560 FDA UDI878.4590 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ultrasound hyperthermia system transducer, extracorporeal
Ulthera System Transducer by Ulthera Inc — Class II — FDA_510K — listed in FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Similar devices
Also classified as Ultrasound hyperthermia system transducer, extracorporeal.
- LIPOcel — Jeisys Medical Incorporated · Class II
- Ulthera System Transducer — Ulthera Inc · Class II
- Ulthera System Handpiece — Ulthera Inc · Class II
- Ulthera System Transducer — Ulthera Inc · Class II
- Ulthera System Transducer — Ulthera Inc · Class II
- Ulthera System Transducer — Ulthera Inc · Class II
- Ulthera System Transducer — Ulthera Inc · Class II
- Ulthera System Transducer — Ulthera Inc · Class II
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 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
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K260618 | Class II | Active |
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Manufacturer
- Manufacturer
- Ulthera Inc
- FDA Applicant
- Ulthera, Inc.
Sources (2)
- FDA UDI 65ad2df0-b325-492c-a90b-4d6210f927f6 57 fields · synced Jun 18, 2026
- FDA 510(k) K260618 1 fields · synced Jun 4, 2026