Ulthera System (Ultherapy)
HIFU/Ultrasound Lifting · Microfocused ultrasound + DeepSEE imaging
Technology: HIFU & Ultrasound
Classification & configurations
Category group: Skin tightening & remodeling (RF microneedling, monopolar RF, HIFU)
At a glance
- New-unit reference · older model
- $130k–$175kSource not documented
- Used asking price
- $20k–$60kSource 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
- FDA
- FDA ClearedDe Novo: DEN080006, K121700, K122528, K132028, K134032, K180623, K233996, K243035, K250418, K260618
- 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.
- The calculator may include a labeled planning estimate. Review it or enter your own allowance; missing data never means $0.
Figures are reference points, not current offers. Used asking prices are not completed-sale values.
Read FDA-cleared indicationsExact wording from 10 FDA records
1064nm: The Cynosure Affirm Family laser is intended for the coagulation and hemostasis of benign vascular lesions, such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), Caf6 au lait macules, seborrheic keratoses, nevi, chloasma, verrucea, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. 1320nm: The Cynosure Affirm Family laser is indicated for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue. It is also indicated for the treatment of periorbital and perioral wrinkles. It is also indicated for the treatment of fine lines and wrinkles. 1440nm: The Cynosure Affirm Family laser is indicated for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue. It is also indicated for the treatment of periorbital and perioral wrinkles and pigmented lesions. The XPL Pulsed Light System Handpiece is intended for permanent hair reduction and the treatment of dermatological vascular lesions, facial and leg veins, benign pigmented lesions, and inflammatory acne. The Affirm Family System Laser Attachment is intended for: Er:YAG 2,940 nm - for skin resurfacing and for the incision, excision, ablation or vaporization of soft bodily tissues.
Verbatim from the FDA De Novo decision summary, retrieved 8 Sep 2026.
K121700 (Ulthera, Inc., 2012)
The Ulthera System is indicated for use as a non-invasive dermatological aesthetic treatment to: • lift the eyebrow (current cleared indication) • lift lax submental (beneath the chin) and neck tissue (requested expanded indication)
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K122528 (Ulthera, Inc., 2012)
The Ulthera' System is indicated for use as a non-invasive dermatological aesthetic treatment to: * lift the eyebrow Description of Change: The proposed change is to extend the current six-month shelf life period to a twelve-month shelf life period for the UltheraO System Transducers.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K132028 (Ulthera, Inc., 2013)
The Ulthera System is indicated for use as a non-invasive dermatological aesthetic treatment to: • lift the eyebrow (current cleared indication) • lift lax submental (beneath the chin) and neck tissue (cleared indication). 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 (requested indication) • confirm appropriate depth of treatment such as to avoid bone (requested indication)
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K134032 (Ulthera, Inc., 2014)
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 • 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.
K180623 (Ulthera, Inc., 2018)
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.
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.
K243035 (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.
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–$175k. Reference figures, not current offers. Used asking prices are not completed-sale values.
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 | Ulthera (Merz) |
|---|---|
| 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 | Ulthera |
| Built by (OEM) | Ulthera Inc. |
| Category | HIFU/Ultrasound Lifting |
| Technology | Microfocused ultrasound + DeepSEE imaging |
| FDA status | FDA Cleared |
| 510(k) citation | De Novo: DEN080006, K121700, K122528, K132028, K134032, K180623, K233996, K243035, K250418, K260618 |
| New-unit reference (older model) | $130k–$175k |
| Used asking range | $20k–$60k |
| Consumables | Not published |
| Launch year | 2009 |
| Pricing | Not published |
| Manufacturer-source documents checked | Not published |
Overview
US lift claim marketed for years (FDA status under verification — see our FDA guide); transducers consumable
How it worksTechnology and manufacturing
How the technology works
Microfocused ultrasound with visualization (MFU-V): the transducer images the tissue plane in real time (DeepSEE), then delivers focused thermal coagulation points at precise depths — 4.5mm (SMAS/platysma), 3.0mm (deep dermis), 1.5mm (superficial dermis) — triggering neocollagenesis and gradual lift over 2-6 months.
Marketed with "lift" language for brow, submental, and neck, plus decollete wrinkle improvement (FDA status under verification — see our FDA guide). Results are line-count-dependent; skimped counts are the #1 cause of "Ultherapy didn't work" reviews.
Patented technology
DeepSEE is the real differentiator — transducer ultrasound imaging confirms coupling and target depth before firing, which no blind-delivery HIFU clone offers. "See what you treat" is load-bearing, not just branding.
Origin
Mesa, Arizona, USA (Ulthera, Inc., a Merz Aesthetics company).
FDA & regulatory detailClearance timeline, authorization route and citation notes
Launch 2009 · Clearance 2009 · Clearance 2012 · Clearance 2014 · Clearance 2024 · Clearance 2025 · DEN080006; K121700; K122528; K132028; K134032; K180623; K233996; K243035; K250418; K260618
De Novo: DEN080006 (decision 11 Sep 2009). 510(k): K121700, K122528, K132028, K134032, K180623, K233996, K243035, K250418 and K260618. Checked 4 Sep 2026.
FDA-cleared indications (verbatim)
1064nm: The Cynosure Affirm Family laser is intended for the coagulation and hemostasis of benign vascular lesions, such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), Caf6 au lait macules, seborrheic keratoses, nevi, chloasma, verrucea, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. 1320nm: The Cynosure Affirm Family laser is indicated for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue. It is also indicated for the treatment of periorbital and perioral wrinkles. It is also indicated for the treatment of fine lines and wrinkles. 1440nm: The Cynosure Affirm Family laser is indicated for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue. It is also indicated for the treatment of periorbital and perioral wrinkles and pigmented lesions. The XPL Pulsed Light System Handpiece is intended for permanent hair reduction and the treatment of dermatological vascular lesions, facial and leg veins, benign pigmented lesions, and inflammatory acne. The Affirm Family System Laser Attachment is intended for: Er:YAG 2,940 nm - for skin resurfacing and for the incision, excision, ablation or vaporization of soft bodily tissues.
Verbatim from the FDA De Novo decision summary, retrieved 8 Sep 2026.
K121700 (Ulthera, Inc., 2012)
The Ulthera System is indicated for use as a non-invasive dermatological aesthetic treatment to: • lift the eyebrow (current cleared indication) • lift lax submental (beneath the chin) and neck tissue (requested expanded indication)
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K122528 (Ulthera, Inc., 2012)
The Ulthera' System is indicated for use as a non-invasive dermatological aesthetic treatment to: * lift the eyebrow Description of Change: The proposed change is to extend the current six-month shelf life period to a twelve-month shelf life period for the UltheraO System Transducers.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K132028 (Ulthera, Inc., 2013)
The Ulthera System is indicated for use as a non-invasive dermatological aesthetic treatment to: • lift the eyebrow (current cleared indication) • lift lax submental (beneath the chin) and neck tissue (cleared indication). 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 (requested indication) • confirm appropriate depth of treatment such as to avoid bone (requested indication)
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K134032 (Ulthera, Inc., 2014)
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 • 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.
K180623 (Ulthera, Inc., 2018)
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.
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.
K243035 (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.
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 — Microfocused ultrasound + DeepSEE imaging
Marketing claims are the manufacturer's own and are not the same as a cleared indication.
510(k) numbers
De Novo: DEN080006, K121700, K122528, K132028, K134032, K180623, K233996, K243035, K250418, K260618
View supporting FDA record.Parent company: Merz Aesthetics
Legal manufacturer: Ulthera Inc. (United States)
Applicant on the FDA record
Ulthera, Inc.The 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: Ulthera Inc.
- 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.
- Vendor restrictions: card-metered — license cards or dongles gate treatments
Source notes
Transducer listings (Starlight, MNML Aesthetics) with per-treatment figures derived from price and rated treatment life; chip-gated cartridge grouping per Beautrek. 30 Aug 2026 research pass.
Annual service & support
No annual service cost documented yet.
Payback calculatorModel your own volume, labor and service costs
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ComplianceScreening and contraindications on the manufacturer's record
Contraindications & screening
Open lesions or severe cystic acne in the area, implanted electrical devices, caution over metal implants/filler along planned lines, pregnancy, anticoagulation per protocol, and severe-laxity patients who need surgery.
Warranty & serviceWhat to confirm in writing before you buy
Before buying new or used, confirm in writing:
- Current warranty coverage
- Included training
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History6 tracked changes
Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.
September 4, 2026
FDA status
Unknown → Cleared
Clearance located on openFDA
Source: Council round 2 audit, verified on openFDA 2026-09-04
September 4, 2026
FDA status
Unknown → Cleared
Source: Catalog update
September 4, 2026
FDA source URL
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN080006
Source: Catalog update
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
August 1, 2026
Record created
Added to The Aesthetic Index — August 2026
Source: The Aesthetic Index editorial
Cite this data: The Aesthetic Index, "Ulthera System (Ultherapy) — pricing, FDA status and cost to own", aestheticindex.co (accessed September 24, 2026).
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