Ulthera® System

K260618 · Ulthera, Inc. · OHV · May 21, 2026 · General, Plastic Surgery

Device Facts

• Record ID: K260618
• Device Name: Ulthera® System
• Applicant: Ulthera, Inc.
• Product Code: OHV · General, Plastic Surgery
• Decision Date: May 21, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4590
• Device Class: Class 2
• Attributes: Therapeutic, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K260618 · May 21, 2026	Ulthera® System	Ulthera, Inc.	Clinician-reported real-world data (RWD); Global post-market surveillance (PMS) data	RWD and PMS data were used to supplement clinical literature to demonstrate the safety and effectiveness of the Ulthera System for the expanded indication of treating skin laxity on the knees, specifically monitoring for adverse events such as joint, muscle, or tendon damage.	Real-world data; Post-market surveillance; Safety monitoring; Knee laxity

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Real-world data collection; Retrospective collection of clinician-reported data	Patients treated for knee skin laxity in routine clinical practice	Not applicable for this study	Safety (adverse events, specifically joint, muscle, or tendon damage)
Global Post-Market Surveillance; Post-market surveillance	Global patient population treated with the Ulthera System	Not applicable for this study	Safety (orthopedic-based adverse events of the knee)

Indications for Use

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

Device Story

System uses micro-focused ultrasound energy to induce thermal coagulation in dermal/subdermal tissue; results in skin contraction/tightening. Input: acoustic waves directed to treatment area; supplemental ultrasound imaging (DeepSEE transducer) for visualization up to 8mm depth. Output: visual display of tissue layers for operator guidance. Used in clinical settings by trained medical professionals. Imaging ensures proper transducer coupling and depth confirmation to avoid bone. Benefits: non-invasive aesthetic improvement of skin laxity and wrinkles; no hardware/software changes from predicate.

Clinical Evidence

Evidence includes a literature search identifying three clinical studies (n=44 total) evaluating knee skin laxity improvement. Endpoints included blinded clinician photographic assessment, Global Aesthetic Improvement Scores (GAIS), and patient satisfaction surveys. Results showed clinically significant improvement up to 180 days post-treatment. Safety data from studies and real-world evidence showed no unexpected adverse events, specifically no joint, muscle, or tendon damage.

Technological Characteristics

Focused ultrasound stimulator; low-energy acoustic deposition. System components: control console, handpiece, interchangeable transducers. Imaging: DeepSEE transducer (up to 8mm depth). Connectivity: USB Wi-Fi adapter. Power: 100-240 VAC. Software: version 2.1.6400, Windows 10 OS. Electrical safety: compliant with IEC standards.

Indications for Use

Indicated for adult patients seeking non-invasive dermatological aesthetic treatment to lift eyebrows, lift lax submental and neck tissue, improve décolleté lines/wrinkles, and improve skin laxity on the abdomen, anterior/posterior arms, and knees.

Regulatory Classification

Identification

A Focused Ultrasound Stimulator System for Aesthetic Use is a device using focused ultrasound to produce localized, mechanical motion within tissues and cells for the purpose of producing either localized heating for tissue coagulation or for mechanical cellular membrane disruption intended for noninvasive aesthetic use.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.

Predicate Devices

• Ulthera® System (UC-1 Control Unit PRIME) (K250418)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

May 21, 2026

Ulthera, Inc.
Scott Jewett
Regulatory Affairs Manager
6501 Six Forks Rd.
Raleigh, North Carolina 27560

Re: K260618
Trade/Device Name: Ulthera® System
Regulation Number: 21 CFR 878.4590
Regulation Name: Focused Ultrasound Stimulator System For Aesthetic Use
Regulatory Class: Class II
Product Code: OHV, IYO
Dated: February 25, 2026
Received: February 25, 2026

Dear Scott Jewett:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K260618 - Scott Jewett
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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K260618 - Scott Jewett
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Sincerely,

Colin K. Chen -S

Digitally signed by
Colin K. Chen -S
Date: 2026.05.21
21:49:12 -04'00"

Colin K. Chen, Ph.D.
Acting Assistant Director
DHT4A: Division of General Surgery Devices
OHT4: Office of Surgical and
Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K260618 | |
| Device Name Ulthera® System | |
| Indications for Use (Describe) 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 | |
| Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. "DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |

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Ulthera, Inc.
K260618
510(k) Summary
Traditional 510(k)
Ulthera® System Expanded Indications (Knees)

# 510(k) Summary

## 1 APPLICANT

Company's Name: Ulthera, Inc.
Company's Address: 6501 Six Forks Road
Raleigh, NC 27615
Telephone: [phone]
Contact Person: Scott Jewett, Regulatory Affairs Manager
Date Prepared: 12 May 2026

## 2 DEVICE

Device Name: Ulthera® System
Classification Name: Focused Ultrasound Stimulator System for Aesthetic Use
21 C.F.R § 878.4590, Focused Ultrasound Stimulator Use
Regulatory Class: Class II
Product Codes: OHV, IYO
Applicable Guidances: Focused Ultrasound Stimulator System for Aesthetic Use
Marketing Clearance of Diagnostic Ultrasound Systems and Transducers

## 3 PREDICATE DEVICE

Ulthera® System (UC-1 Control Unit PRIME), Ulthera, Inc., K250418

Page 1 of 5

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Ulthera, Inc. Ulthera® System Expanded Indications (Knees)

K260618

510(k) Summary Traditional 510(k)

# 4 DEVICE DESCRIPTION

The Ulthera® System consists of the Ulthera® Control Unit (with system software), a handpiece with cable, and interchangeable transducers. The device produces controlled tissue coagulation below the skin surface (epidermis) within the first few millimeters of tissue (dermis) using highly focused, low-energy ultrasound deposition. The Ulthera® System directs micro-focused acoustic waves to the treatment area at desired depths without affecting or requiring a secondary action to protect the skin surface. The operator may also use the device's supplemental imaging capability to visualize the treatment area and aid in assuring full/proper skin contact of the Ulthera® System transducer to the skin in the target area.

# 5 INTENDED USE / INDICATIONS FOR USE

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

# 6 SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

The purpose of this 510(k) notification relates to expanded indications for the Ulthera® System to improve the appearance of skin laxity on the knees. Low-intensity, highly focused ultrasound is the main technological principle of both the subject and the predicate device. In both devices, focused ultrasound energy is delivered below the skin and produces discrete points of thermal coagulation that results in contraction of the skin, which produces a lifting or tightening effect and improves appearance of lax tissue, lines, and wrinkles. There are no changes in design, hardware, or software between subject and predicate device. Comparison between the subject and predicate device are summarized in Table 1 below:

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Ulthera, Inc.
Ulthera® System Expanded Indications (Knees)
K260618
510(k) Summary
Traditional 510(k)

Table 1: Substantial Equivalence Table Comparing Subject & Predicate Device

| | Ulthera® System (Subject) | Ulthera® System K250418 (Predicate) | Similarities and significant differences to the predicate |
| --- | --- | --- | --- |
| Intended Use | 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 intended to apply focused ultrasound energy to the body to achieve temporary changes in the physical appearance of the skin. | Identical |
| Indications for Use | 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 | 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 | Different Additional indications added for the knees. Clinical data, real-world evidence (RWE), and post market surveillance (PMS) data have been provided to demonstrate the safety and effectiveness of the device for the expanded indications and support the expansion of the subject device’s indications for use. |
| User Population | Treatment of adult patient population by trained medical professional | Treatment of adult patient population by trained medical professional | Identical |
| Main System Components | • Control console • Handpiece • Transducers | • Control console • Handpiece • Transducers | Identical |
| Additional Components Required for Operation | • ACLF Power Cord with pigtail adapter • Wibu USB Access Key | • ACLF Power Cord with pigtail adapter • Wibu USB Access Key | Identical |
| Console Dimensions | Height: <16.69" (424 mm) Width: 19.4" (493.6 mm) Depth: 13.1" (333 mm) | Height: <16.69" (424 mm) Width: 19.4" (493.6 mm) Depth: 13.1" (333 mm) | Identical |

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Ulthera, Inc.
Ulthera® System Expanded Indications (Knees)
K260618
510(k) Summary
Traditional 510(k)

| | Ulthera® System (Subject) | Ulthera® System K250418 (Predicate) | Similarities and significant differences to the predicate |
| --- | --- | --- | --- |
| Console Connection Ports | 6 | 6 | Identical |
| Weight | Weight: ≤27 lbs (12.2 kg) | Weight: ≤27 lbs (12.2 kg) | Identical |
| Display | 18.5” screen; aspect ratio of 16:9 with 1920 x 1080 resolution | 18.5” screen; aspect ratio of 16:9 with 1920 x 1080 resolution | Identical |
| Power Source | 100-240 VAC, 50/60 Hz, 3A max Fuse: (2) 5x20mm, 6.3A fast acting, 250V | 100-240 VAC, 50/60 Hz, 3A max Fuse: (2) 5x20mm, 6.3A fast acting, 250V | Identical |
| Software | version 2.1.6400 | version 2.1.6400 | Identical |
| Treatment Modes | Amplify See.Plan.Treat | Amplify See.Plan.Treat | Identical |
| Ultrasound Color Maps | Black & White (monochromatic) Bone (blue scale) Twilight (multicolor) | Black & White (monochromatic) Bone (blue scale) Twilight (multicolor) | Identical |
| Wireless Connectivity | Connection via USB Wi-Fi Adapter | Connection via USB Wi-Fi Adapter | Identical |
| Operating System | Windows 10 | Windows 10 | Identical |
| Electrical Safety & EMC | Compliant with relevant IEC standards for console and ACLF power cord | Compliant with relevant IEC standards for console and ACLF power cord | Identical |

# 7 PERFORMANCE DATA

## 7.1 Clinical Testing

To support the device’s indications for use, a comprehensive literature search was performed, and three (3) unique clinical studies were identified that used the Ulthera® System to improve the appearance of skin laxity on the knees. These studies included 44 total subjects, which is comparable to and/or exceeds the number of subjects evaluated in the previous 510(k) clearances for the Ulthera® System and other focused ultrasound stimulator systems for aesthetic use.

These clinical studies demonstrated clinically significant skin improvement up to 180 days post-treatment via a variety of endpoints, including blinded clinician photographic assessment, physician and subject Global Aesthetic Improvement Scores (GAIS), and patient satisfaction surveys. From a safety perspective, there were no unexpected or severe adverse events (AEs), and all observed AEs resolved without long-term sequelae.

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Ulthera, Inc.
Ulthera® System Expanded Indications (Knees)
K260618
510(k) Summary
Traditional 510(k)

Additionally, the Company also obtained real-world data (RWD) gathered from clinicians who regularly treat the knee region with the Ulthera® System. No unexpected adverse events were reported, including no reports of joint, muscle, or tendon damage.

Lastly, there has not been any orthopedic-based adverse events of the knee reported from global post marketing surveillance of the device. Collectively, the totality of evidence supports the safety of the Ulthera® System for treating the knees.

# 8 CONCLUSIONS

The subject device has the same general intended use and principle of operation as the predicate device, and there have been no changes in device hardware, software, or firmware compared to the predicate device. An analysis of clinical, real-world, and post marketing data demonstrates that the device is as safe and effective as the predicate device for the requested indications for use.

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