Equipment profile · Merz Aesthetics
Ultherapy PRIME: Price, Specs, FDA Clearance and Alternatives
Ultherapy PRIME is Merz Aesthetics’ current Ultherapy console: microfocused ultrasound that heats the deep support layers of the skin without breaking the surface, with live imaging so the provider sees the tissue before each line. Patients know the Ultherapy name, and the imaging is what sets it apart from most needle-free lifting devices.
The short answer
Ultherapy PRIME is cleared to lift the brow and the tissue under the chin and neck and to improve décolleté lines; 2025 and 2026 records add skin laxity on the abdomen, arms and knees. FDA’s 2024 PRIME record covered console changes, not a new treatment technology. Merz doesn’t publish prices, and transducers are the main running cost.
Who should buy an Ultherapy PRIME?
Shortlist it if
- Patients ask for Ultherapy by name, and you want to be listed as a provider.
- You want needle-free lifting with imaging that shows treatment depth.
- You have a pain-management protocol your patients accept.
Compare another option if
- You want needle-free RF, which matched it in a split-face trial: compare Thermage FLX.
- You want facial treatment with muscle stimulation: compare EMFACE.
Our take: Ultherapy or Thermage?
Choose on demand and running costs; neither is a clear clinical winner. A 2019 randomized split-face trial found microfocused ultrasound with visualization and monopolar RF similar for laxity at six months. Ultherapy’s imaging is a real safety feature, and rare burns and fat loss have been reported, so training matters.
Work out the transducer cost of one full-face treatment and set it beside a Thermage FLX quote’s tip cost for the same patient. That comparison tells you more about margin than the console price does.
Comparing it with Thermage FLX? See Thermage FLX vs Ultherapy PRIME, side by side.
Document-based buying analysis. Not a NuWays MD hands-on test of this device.
Ultherapy PRIME specifications at a glance
Before you compare
| Specification | Ultherapy PRIME | What it means for your practice |
|---|---|---|
| Technology | Focused ultrasound that creates small points of thermal coagulation below the skin (FDA record) | Treats deeper layers without breaking the skin. |
| Imaging | DeepSEE transducers image up to 8 mm deep to confirm skin contact and treatment depth (FDA record) | Helps keep depth consistent and avoid bone. |
| Console | 19-inch high-resolution touchscreen, quieter system sounds and faster operation (Merz) | |
| Cleared areas | Brow, under the chin and neck, décolleté lines; abdomen and arms (2025); knees (2026) (FDA records) | Newer body areas need the newer software; confirm your console has it. |
| Transducers | Interchangeable transducers for different treatment depths (Ulthera device listings) | Ask how many treatment lines each delivers and what replacements cost. |
Sources: Merz Aesthetics · FDA 510(k) K260618.
See it next to the alternativesSpecs, cleared uses and ownership questions in one table.
What is the Ultherapy PRIME FDA cleared for?
Each 510(k) number links to its record in the FDA database. The summary PDFs are listed under Sources.
510(k) K260618 (Ulthera System), cleared May 21, 2026. Product code OHV; Class II medical device. Adds skin laxity on the knees.
| Area | Cleared uses (summarized) |
|---|---|
| Face and neck | Lift the eyebrow; lift lax submental and neck tissue. |
| Body | Improve lines and wrinkles of the décolleté; improve the appearance of skin laxity on the abdomen, front and back of the arms, and knees. |
| Imaging | DeepSEE imaging to 8 mm to ensure coupling and confirm treatment depth, such as to avoid bone. |
Source: FDA 510(k) K260618.
510(k) K250418 (Ulthera System (UC-1 Control Unit PRIME Model 2.1)), cleared May 13, 2025. Product code OHV; Class II medical device. Adds the abdomen and arms.
Source: FDA 510(k) K250418.
510(k) K233996 (Ulthera System (UC-1 Control Unit PRIME)), cleared February 22, 2024. Product code OHV; Class II medical device. Clears the PRIME console changes.
Source: FDA 510(k) K233996.
Clearance describes what a device may be marketed for; it does not predict results for a given patient.
Ultherapy PRIME clinical studies
Published studies we found on this system, its earlier models and related technology, each labeled by what it tested. Most are small, and some have manufacturer-affiliated authors, so use them to frame questions for the demo rather than as proof of results.
What we found: None on this system; 2 on earlier models.
- Earlier model: Ultherapy, before PRIMEA Randomized, Split-Face, Evaluator-Blind Clinical Trial Comparing Monopolar Radiofrequency Versus Microfocused Ultrasound With Visualization for Lifting and Tightening of the Face and Upper NeckMicrofocused ultrasound with visualization (Ultherapy’s technology) on one side, monopolar RF on the other; both improved laxity through 6 months with no significant difference.
- Earlier model: Ultherapy, before PRIMEComplications from microfocused transcutaneous ultrasound: Case series and review of the literatureBlistering, ulceration, fat atrophy and skin necrosis after single Ultherapy sessions. Rare, but the authors say serious events may be underreported.
Links open the PubMed record.
How much does an Ultherapy PRIME cost?
| Price evidence | What we found |
|---|---|
| New system (manufacturer quote) | Merz does not publish prices, and we found no reliable public price for a new Ultherapy PRIME. |
| Used (asking prices) | Not reviewed for this profile. Confirm the console (PRIME or earlier) and transducer line counts on any used unit. |
| Documented sale prices | None found. |
What ownership adds after purchase
| Cost area | What to confirm |
|---|---|
| Transducers | Ask how many treatment lines each transducer delivers, replacement prices and any warranty on them. |
| Software | Confirm the console runs the software for the newer body areas. |
| Comfort | Plan your pain-management protocol; budget any medication or numbing supplies. |
| Service | Ask what the warranty covers and what service costs after it ends. |
Ultherapy PRIME alternatives to compare
| Device | Technology | Why compare it |
|---|---|---|
| Solta Medical Thermage FLX | Monopolar RF, 6.78 MHz | Solta’s monopolar RF; a 2019 split-face trial found similar laxity results. |
| Jeisys Density | Non-invasive monopolar and bipolar RF | Jeisys’s monopolar and bipolar RF tightening. |
| BTL EMFACE | Synchronized RF and HIFES facial muscle stimulation | BTL’s RF with facial muscle stimulation and an under-chin applicator. |
Different technologies are not interchangeable. Compare configurations, cleared uses and ownership costs before you book demos.
Questions to ask before you sign
- Ultherapy PRIME or an earlier console, and which software version?
- Which transducers are included, how many lines does each deliver, and what do replacements cost?
- Does the console include the newer body indications?
- How many training days are included, and is there treatment-planning support?
- What does the warranty cover, and what does service cost after it ends?
- What is the total with tax, freight and financing?
Plan the purchase
Plan your Ultherapy PRIME purchase.
- Compare it side by side with its closest alternatives.
- Check what each quote includes: configuration, supplies, service and financing.
- Model the monthly payment against realistic treatment volume in the ROI calculator.
Other skin tightening machines to research
InModeDefineFull profileHands-free and handheld bipolar RF plus Morpheus8Read the full page →
Solta MedicalThermage FLXFull profileMonopolar RF, 6.78 MHzRead the full page →
JeisysDensityFull profileNon-invasive monopolar and bipolar RFRead the full page →
BTLEMFACEFull profileSynchronized RF and HIFES facial muscle stimulationRead the full page →All skin tightening machines →More Merz Aesthetics equipment →Full equipment catalog →
Sources
Show all 4 sources
- Merz Aesthetics: Ultherapy PRIME for physicians (November 7, 2026). Checked November 7, 2026.
- FDA 510(k) K260618: Ulthera System (May 21, 2026). Checked November 7, 2026.
- FDA 510(k) K250418: Ulthera System (UC-1 Control Unit PRIME Model 2.1) (May 13, 2025). Checked November 7, 2026.
- FDA 510(k) K233996: Ulthera System (UC-1 Control Unit PRIME) (February 22, 2024). Checked November 7, 2026.