Last source review: 2026-09-09. This date does not mean that every specification has been verified.
At a glance
| Brand / company | Ulthera, Inc. [1] |
|---|---|
| Technology | Focused ultrasound |
| Energy category | Microfocused ultrasound [1] |
| RF frequency (MHz) | Not yet verified |
| Wavelength (nm) | Not yet verified |
| Launch year | Not yet verified |
| Tips / consumables | Interchangeable transducers. The 510(k) describes the system as a control unit with system software, a handpiece with cable and interchangeable transducers. [1] |
Reading this record
A platform described with microfocused ultrasound and real-time imaging. This record summarizes the manufacturer material linked below. It does not independently establish clinical effectiveness or local regulatory clearance.
Regulatory record
US FDA 510(k) K233996, found substantially equivalent on 2024-02-22. Applicant Ulthera, Inc., regulation 21 CFR 878.4590, product codes OHV and IYO, Class II. The device name on the record is Ulthera System (UC-1 Control Unit PRIME) and the predicate is K180623. Indications: lift the eyebrow; lift lax submental and neck tissue, which can also affect the appearance of lax tissue in the submental and neck regions; improve lines and wrinkles of the décolleté. Used with the DeepSEE transducer the record covers ultrasonic visualization of depths up to 8 mm below the skin surface, for confirming transducer coupling and treatment depth. The Korean MFDS record has not been checked. Source ↗
Still to be checked
Numerical parameters, configuration-specific consumables, model history and market-specific regulatory records need separate document checks. An unverified field means the work is unfinished, not that the device lacks the feature.
Sources reviewed
- Ultherapy PRIME — Merz Aesthetics ↗Manufacturer material · Accessed 2026-09-08
- FDA 510(k) K233996 — Ulthera System (UC-1 Control Unit PRIME) ↗Regulatory record · Accessed 2026-09-09
- FDA 510(k) Summary K233996 — Ulthera System Console Modifications ↗Regulatory record · Accessed 2026-09-09