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Sign in to claim this brandUlthera Inc
US
Last updated September 17, 2026
What Ulthera Inc makes
Ulthera Inc manufactures ultrasonic skin and body contouring systems, including handheld devices and transducer units that deliver focused ultrasound energy for non-invasive tissue remodeling. Their portfolio also includes mechanical skin contouring systems, such as motorized modules and disposable injection/transection sets, designed for subcutaneous tissue treatment. Additionally, they produce electromechanical accessories like transport trolleys and operating table attachments to support procedural workflows. These systems are intended for aesthetic and therapeutic applications targeting skin laxity and volume loss.
The company’s devices are classified under FDA regulations as Class I and Class II, with most products listed in the FDA’s Unique Device Identifier (UDI) database. Their systems are intended for use in clinical settings and are subject to compliance with U.S. medical device regulations. Ulthera Inc operates from the United States, adhering to domestic regulatory requirements for device authorization and post-market surveillance.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- 6501 Six Forks Rd, Raleigh, NC, 27615
- Website
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- —
- —
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1012187
- DUNS Number
- —
Catalogue (80)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ulthera System Handpiece | UH-2 Rev. B | FDA UDI | Class II | Active |
| Cellfina Prep Pack | CP1 Rev G | FDA UDI | Class II | Active |
| Cellfina System Procedure Kit (Single Package) | CK1-1 Rev. A | FDA UDI | Class II | Unknown |
| Ulthera System Control Unit | UC-1 Rev. G | FDA UDI | Class II | Active |
| Cellfina Prep Pack for EU | CP1 Rev B | FDA UDI | Class II | Unknown |
| Cellfina Prep Pack | CP1 Rev D | FDA UDI | Class II | Active |
| Cellfina System Disposable Tray | CK1 rev M | FDA UDI | Class II | Unknown |
| Cellfina Motor Module Device and Package | CM1 Rev D | FDA UDI | Class II | Unknown |
| Ulthera System Control Unit | UC-1 Rev. A | FDA UDI | Class II | Active |
| Ulthera System Transducer | UT-1N Rev. H | FDA UDI | Class II | Active |
| Cellfina System Disposable Tray | CK1 Rev. F | FDA UDI | Class II | Active |
| Cellfina | CK1-EU Rev A | FDA UDI | Class II | Unknown |
| Ulthera System Transducer | UT-4 Rev. F | FDA UDI | Class II | Active |
| Ulthera System Handpiece | UH-2 Rev N | FDA UDI | Class II | Active |
| Ulthera System Transducer | UT-4 Rev. G | FDA UDI | Class II | Active |
| Ulthera System Handpiece | UH-2 Rev. 1 | FDA UDI | Class II | Active |
| Ulthera System Transducer | UT-4 Rev L | FDA UDI | Class II | Active |
| Ulthera System | K134032 | FDA 510(k) | Class II | Active |
| Ulthera System (UC-1 Control Unit PRIME) | K233996 | FDA 510(k) | Class II | Active |
| The Cellfina System | K153677 | FDA 510(k) | Class II | Active |
| Ulthera System | K122528 | FDA 510(k) | Class II | Active |
| Ulthera System | K121700 | FDA 510(k) | Class II | Active |
| Ulthera System | K132028 | FDA 510(k) | Class II | Active |
| Ulthera System (UC-1 Control Unit PRIME Model 2.1) | K250418 | FDA 510(k) | Class II | Active |
| Ulthera® System | K243035 | FDA 510(k) | Class II | Active |
| Cellfina System | K150505 | FDA 510(k) | Class II | Active |
| Ulthera System | K180623 | FDA 510(k) | Class II | Active |
| The Cellfina System | K161885 | FDA 510(k) | Class II | Active |
| The Cellfina System | K192185 | FDA 510(k) | Class II | Active |
| Ulthera System, Model 8850-0001 | DEN080006 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
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Importers
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Authorities
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Ulthera Inc. has one FDA recall record initiated on 2016-11-14, which is marked as terminated. The recall was due to the inclusion of a non-sterile vacuum tube in the product packaging, despite the Instructions for Use specifying the use of a sterile vacuum tube.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Nov 14, 2016 | Z-0749-2017 | — | terminated | It was discovered that a non-sterile vacuum tube is supplied within the pack, although the Instructions for Use (IFU) describe the use of a sterile vacuum tube as part of the procedure setup. |