Merz Aesthetics Ultherapy PRIME
HIFU/Ultrasound Lifting · Next-gen MFU-V with enhanced imaging
Technology: HIFU & Ultrasound
Classification & configurations
Category group: Skin tightening & remodeling (RF microneedling, monopolar RF, HIFU)
At a glance
- New price
- $150k–$200kSource not documented
- FDA status
- Supplies & recurring costs
- See supply and replacement costs below.
Sources and verified data on file
Data on file
- Recurring consumables
- Not verified
- Used asking prices
- Not verified
- This panel shows a per-treatment supply cost only when a recorded figure has a dated source.
- Bottle prices and estimates may still appear under Treatment & running costs.
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Figures are reference points, not current offers.
Read FDA-cleared indicationsExact wording from 3 FDA records
K233996 (Ulthera, Inc., 2024)
The Ulthera System is intended to apply focused ultrasound energy to the body to achieve temporary changes in the physical appearance of the skin. The Ulthera System is indicated for use as a non-invasive dermatological aesthetic treatment to: • Lift the eyebrow • Lift lax submental (beneath the chin) 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. The Ulthera® System, in conjunction with the Ulthera® DeepSEE® transducer, allows for ultrasonic visualization of depths up to 8 mm below the surface of the skin. The indicated use of the imaging is to visualize the dermal and subdermal layers of tissue to: • Ensure proper coupling of the transducer to the skin • Confirm appropriate depth of treatment such as to avoid bone
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K250418 (Ulthera, Inc., 2025)
The Ulthera System is intended to apply focused ultrasound energy to the body to achieve temporary changes in the physical appearance of the skin. The Ulthera® System is indicated for use as a non-invasive dermatological aesthetic treatment to: • lift the eyebrow • lift lax submental (beneath the chin) 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 • improve the appearance of skin laxity on the abdomen, anterior arms, and posterior arms. The Ulthera® System in conjunction with the Ulthera® DeepSEE transducer allows for ultrasonic visualization of depths up to 8 mm below the surface of the skin. The indicated use of the imaging is to visualize the dermal and subdermal layers of tissue to: • ensure proper coupling of the transducer to the skin • confirm appropriate depth of treatment such as to avoid bone
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K260618 (Ulthera, Inc., 2026)
The Ulthera® System is intended to apply focused ultrasound energy to the body to achieve temporary changes in the physical appearance of the skin. The Ulthera® System is indicated for use as a non-invasive dermatological aesthetic treatment to: • lift the eyebrow • lift lax submental (beneath the chin) 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 • improve the appearance of skin laxity on the abdomen, anterior arms, posterior arms, and knees. The Ulthera® System in conjunction with the Ulthera® DeepSEE transducer allows for ultrasonic visualization of depths up to 8 mm below the surface of the skin. The indicated use of the imaging is to visualize the dermal and subdermal layers of tissue to: • ensure proper coupling of the transducer to the skin • confirm appropriate depth of treatment such as to avoid bone
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Page updated: September 4, 2026 · How we verify
Axis runs $0–$200k. Reference figures, not current offers.
Not verified
We hold no per-treatment consumable price for this device from a dated source. Ask the seller for a written per-treatment cost.
Price sourcesSources, dates and configurations
Key factsCompany, specifications and verification dates
| Manufacturer | Merz Aesthetics |
|---|---|
| Company | Owner: Merz Group (Merz Holding GmbH & Co. KG), founding Merz family (family / founder owned, since 1908) · Distribution: direct |
| Parent company | Merz Aesthetics |
| Brand owner | Merz Aesthetics |
| Built by (OEM) | Merz North America |
| Category | HIFU/Ultrasound Lifting |
| Technology | Next-gen MFU-V with enhanced imaging |
| FDA status | FDA Cleared |
| 510(k) citation | K233996, K250418, K260618 |
| New price range | $150k–$200k |
| Used asking range | Not published |
| Consumables | Not published |
| Launch year | 2024 |
| Pricing | Not published |
| Manufacturer-source documents checked | Not published |
Overview
Refresh of Ultherapy platform
How it worksTechnology and manufacturing
How the technology works
Micro-focused ultrasound with visualization (MFU-V). Focused ultrasound beams create tiny thermal coagulation points (~60-70C) at precise depths — 1.5mm, 3.0mm, and 4.5mm — reaching the SMAS/platysma layer that surgeons pull during a facelift, without breaking the skin.
The injury triggers collagen contraction and months of neocollagenesis, producing gradual lift of brow, chin, neck, and decolletage over 2-6 months. The only FDA-cleared ultrasound lifting device with real-time imaging, so the operator confirms energy is landing in tissue, not bone or vessels.
Patented technology
DeepSEE real-time ultrasound imaging lets the provider see tissue layers before firing — genuinely useful for safety and depth targeting, not just marketing. PRIME adds a redesigned handpiece, streamlined UI, and faster line delivery; the underlying MFU-V mechanism is unchanged.
Origin
Developed by Ulthera Inc. (Mesa, Arizona), now Merz Aesthetics; US-based manufacturing — verify current site with Merz.
FDA & regulatory detailClearance timeline, authorization route and citation notes
510(k): K233996, K250418 and K260618. Checked 4 Sep 2026.
FDA-cleared indications (verbatim)
K233996 (Ulthera, Inc., 2024)
The Ulthera System is intended to apply focused ultrasound energy to the body to achieve temporary changes in the physical appearance of the skin. The Ulthera System is indicated for use as a non-invasive dermatological aesthetic treatment to: • Lift the eyebrow • Lift lax submental (beneath the chin) 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. The Ulthera® System, in conjunction with the Ulthera® DeepSEE® transducer, allows for ultrasonic visualization of depths up to 8 mm below the surface of the skin. The indicated use of the imaging is to visualize the dermal and subdermal layers of tissue to: • Ensure proper coupling of the transducer to the skin • Confirm appropriate depth of treatment such as to avoid bone
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K250418 (Ulthera, Inc., 2025)
The Ulthera System is intended to apply focused ultrasound energy to the body to achieve temporary changes in the physical appearance of the skin. The Ulthera® System is indicated for use as a non-invasive dermatological aesthetic treatment to: • lift the eyebrow • lift lax submental (beneath the chin) 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 • improve the appearance of skin laxity on the abdomen, anterior arms, and posterior arms. The Ulthera® System in conjunction with the Ulthera® DeepSEE transducer allows for ultrasonic visualization of depths up to 8 mm below the surface of the skin. The indicated use of the imaging is to visualize the dermal and subdermal layers of tissue to: • ensure proper coupling of the transducer to the skin • confirm appropriate depth of treatment such as to avoid bone
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K260618 (Ulthera, Inc., 2026)
The Ulthera® System is intended to apply focused ultrasound energy to the body to achieve temporary changes in the physical appearance of the skin. The Ulthera® System is indicated for use as a non-invasive dermatological aesthetic treatment to: • lift the eyebrow • lift lax submental (beneath the chin) 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 • improve the appearance of skin laxity on the abdomen, anterior arms, posterior arms, and knees. The Ulthera® System in conjunction with the Ulthera® DeepSEE transducer allows for ultrasonic visualization of depths up to 8 mm below the surface of the skin. The indicated use of the imaging is to visualize the dermal and subdermal layers of tissue to: • ensure proper coupling of the transducer to the skin • confirm appropriate depth of treatment such as to avoid bone
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Marketed for
HIFU / Ultrasound — Next-gen MFU-V with enhanced imaging
Marketing claims are the manufacturer's own and are not the same as a cleared indication.
510(k) applicant of record: Ulthera, Inc. (a Merz Aesthetics subsidiary)
Parent company: Merz Aesthetics
Legal manufacturer: Merz North America (United States)
Applicant on the FDA record
Merz AestheticsThe applicant named on the FDA record can differ from the brand shown on the device.
Regulatory data comes from public FDA records and may lag recent updates. Confirm the applicable status and documentation before purchase.
Look-alike devices
Comparing an unbranded HIFU (focused ultrasound) unit? Check the exact model rather than relying on similar photos or treatment claims.
Listed manufacturer for this profile: Merz North America
- FDA record: Match any claimed 510(k) or De Novo number to the exact model and applicant in the FDA database.
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We do not profile these unbranded units or verify their support and financing terms. This profile’s FDA record applies to the named device, not every similar-looking unit.
Treatment & running costs
Treatments
Sessions & timing
No treatment schedule documented yet.
What practices charge
No sourced treatment price on file.
Supplies & recurring costs
Supply pricing is not documented with a dated source yet. Request an itemized supply quote.
Annual service & support
No annual service cost documented yet.
Payback calculatorModel your own volume, labor and service costs
Estimate your payback
Pre-filled from our published Merz Aesthetics Ultherapy PRIME data where we have it. Estimates appear once the required inputs are available. Review and adjust every pre-filled value before relying on the result.
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Your estimate
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ComplianceScreening and contraindications on the manufacturer's record
Contraindications & screening
Open wounds or severe cystic acne in the area, active implanted electrical devices in the field, pregnancy; screen for recent filler/threads in the target zone and unrealistic expectations (it lifts — it doesn't replace a facelift).
Warranty & serviceWhat to confirm in writing before you buy
Before buying new or used, confirm in writing:
- Current warranty coverage
- Included training
- Service terms
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Current alternatives
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History4 tracked changes
Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.
September 4, 2026
510(k) numbers
K-number set re-verified against openFDA
Source: Council round 2 audit, verified on openFDA 2026-09-04
September 4, 2026
FDA K-numbers
Source: Catalog update
September 4, 2026
FDA source URL
Source: Catalog update
August 1, 2026
Record created
Added to The Aesthetic Index — August 2026
Source: The Aesthetic Index editorial
Cite this data: The Aesthetic Index, "Merz Aesthetics Ultherapy PRIME — pricing, FDA status and cost to own", aestheticindex.co (accessed September 24, 2026).
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