Ulthera® System

K243035 · Ulthera, Inc. · OHV · Feb 24, 2025 · General, Plastic Surgery

Device Facts

• Record ID: K243035
• Device Name: Ulthera® System
• Applicant: Ulthera, Inc.
• Product Code: OHV · General, Plastic Surgery
• Decision Date: Feb 24, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4590
• Device Class: Class 2
• Attributes: Therapeutic

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 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

Device Story

Ulthera System uses micro-focused ultrasound energy to induce thermal coagulation in dermal/subdermal tissue; results in tissue contraction, skin tightening, and lifting. Device comprises control console with touchscreen, handpiece, and interchangeable transducers. Operator uses integrated ultrasound imaging (DeepSEE transducer) to visualize tissue up to 8 mm deep; ensures proper skin coupling and avoids bone. Used in clinical settings by trained medical professionals. Output is visual feedback for the clinician and thermal energy for the patient. Benefits include non-invasive aesthetic improvement of skin laxity and wrinkles. Software update allows user-controlled sound volume during treatment.

Clinical Evidence

Literature review of seven clinical studies (n=167 total) evaluating abdomen (n=54) and arms (n=113). Endpoints included blinded clinician photographic assessment, Global Aesthetic Improvement Scores (GAIS), and patient satisfaction surveys. Results demonstrated clinically significant skin improvement up to 180 days post-treatment. No unexpected or severe adverse events reported; all AEs resolved without long-term sequelae.

Technological Characteristics

Focused ultrasound stimulator; console with 18.5" touchscreen, handpiece, and interchangeable transducers. Operates at 100-240 VAC. Biocompatible user-contacting surfaces. Software version 2.1.2036 running on Windows 10. Compliant with IEC 60601-1 electrical safety standards. Imaging mode provides visualization up to 8 mm depth.

Indications for Use

Indicated for adult patients as a 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 arms, and posterior arms.

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) (K233996)

Submission Summary (Full Text)

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February 24, 2025

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Ulthera, Inc. Scott Jewett Sr. Regulatory Affairs Specialist 6501 Six Forks Road Raleigh, North Carolina 27615

Re: K243035

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: January 28, 2025 Received: January 29, 2025

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"

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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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (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 Rue"). 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-advicecomprehensive-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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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Sincerely,

Image /page/2/Figure/3 description: The image shows a digital signature. The signature is for James H. Jang -S. The signature was created on February 23, 2025 at 20:28:35 -05'00'.

For

Long Chen, Ph.D. 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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# Indications for Use

510(k) Number (if known) K243035

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, 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

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------------------------------------|
| 区 Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary

### 1 APPLICANT

| Company's Name: | Ulthera, Inc. |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company's Address: | 6501 Six Forks Road<br>Raleigh, NC 27615 |
| Telephone: | 919.215.4879 |
| Contact Person: | Scott Jewett, Regulatory Affairs Manager |
| Date Prepared: | 19 February 2025 |
| <b>2 DEVICE</b> | |
| Device Name: | Ulthera System |
| Classification Name: | Focused Ultrasound Stimulator System for Aesthetic Use<br>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<br>Marketing Clearance of Diagnostic Ultrasound Systems and<br>Transducers<br>Content of Premarket Submissions for Software Contained in<br>Medical Devices |

### 3 PREDICATE DEVICE

Ulthera System (UC-1 Control Unit PRIME), Ulthera, Inc., K233996

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### DEVICE DESCRIPTION 4

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.

### INTENDED USE / INDICATIONS FOR USE 5

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

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### SUMMARY OF TECHNOLOGICAL CHARACTERISTICS 6

The purpose of this 510(k) notification relates to expanded indications for the Ulthera System to treat the abdomen, anterior arms, and posterior arms. 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. Both the subject and predicate device share the following similar technological elements:

- . Identical ultrasound signal energy and graphical user interface (GUI).
- Same main components, including a console with integrated touchscreen, connected . handpiece, and interchangeable transducers.
- An imaging mode of operation to visualize the treatment area and aid in assuring ● full/proper skin contact of the transducer to the skin.

The minor design differences between the subject and predicate system's console (e.g., software, hardware, and exterior paint formulation) do not affect clinical functionality or performance specifications of the system and have been verified and tested:

Comparison between the subject and predicate device are summarized in Table 1 below:

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# Table 1: Substantial Equivalence Table Comparing Subject & Predicate Device

| | Ulthera System<br>(Subject Device) | Ulthera System<br>K233996<br>(Predicate) | Similarities and<br>significant<br>differences to the<br>predicate |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Ulthera System is<br>intended to apply focused<br>ultrasound energy to the body<br>to achieve temporary changes<br>in the physical appearance of<br>the skin. | The Ulthera System is<br>intended to apply focused<br>ultrasound energy to the body<br>to achieve temporary changes<br>in the physical appearance of<br>the skin. | Identical |
| Indications for<br>Use | The Ulthera® System is<br>indicated for use as a non-<br>invasive dermatological<br>aesthetic treatment to:<br>lift the eyebrow lift lax submental<br>(beneath the chin)<br>and neck tissue;<br>which can also affect<br>the appearance of lax<br>tissue in the<br>submental and neck<br>regions improve lines and<br>wrinkles of the<br>décolleté Improve the<br>appearance of skin<br>laxity on the<br>abdomen, anterior<br>arms, and posterior<br>arms The Ulthera® System in<br>conjunction with the Ulthera®<br>DeepSEE transducer allows<br>for ultrasonic visualization of<br>depths up to 8 mm below the<br>surface of the skin. The<br>indicated use of the imaging is<br>to visualize the dermal and<br>subdermal layers of tissue to:<br>ensure proper<br>coupling of the<br>transducer to the skin confirm appropriate<br>depth of treatment<br>such as to avoid bone | The Ulthera® System is<br>indicated for use as a non-<br>invasive dermatological<br>aesthetic treatment to:<br>lift the eyebrow lift lax submental<br>(beneath the chin)<br>and neck tissue;<br>which can also affect<br>the appearance of lax<br>tissue in the<br>submental and neck<br>regions improve lines and<br>wrinkles of the<br>décolleté. The Ulthera® System in<br>conjunction with the Ulthera®<br>DeepSEE transducer allows<br>for ultrasonic visualization of<br>depths up to 8 mm below the<br>surface of the skin. The<br>indicated use of the imaging is<br>to visualize the dermal and<br>subdermal layers of tissue to:<br>ensure proper<br>coupling of the<br>transducer to the skin confirm appropriate<br>depth of treatment<br>such as to avoid bone | Different<br>Additional<br>indications added for<br>the abdomen, anterior<br>arms, and posterior<br>arms. Clinical data<br>have been provided<br>to demonstrate the<br>safety and<br>effectiveness of the<br>device for the<br>expanded indications<br>and support the<br>expansion of the<br>subject device's<br>indications for use. |
| User Population | Treatment of adult patient<br>population by trained medical<br>professional | Treatment of adult patient<br>population by trained medical<br>professional | Identical |
| | Ulthera System<br>(Subject Device) | Ulthera System<br>K233996<br>(Predicate) | Similarities and<br>significant<br>differences to the<br>predicate |
| Main System<br>Components | • Control console<br>• Handpiece<br>• Transducers | • Control console<br>• Handpiece<br>• Transducers | Identical |
| Additional<br>Components<br>Required for<br>Operation | • ACLF Power Cord with<br>pigtail adapter<br>• USB Access Key | • ACLF Power Cord with<br>pigtail adapter<br>• USB Access Key | Identical |
| Dimensions | Height: <16.69" (424 mm)<br>Width: 19.4" (493.6 mm)<br>Depth: 13.1" (333 mm) | Height: <16.69" (424 mm)<br>Width: 19.4" (493.6 mm)<br>Depth: 13.1" (333 mm) | Identical |
| Weight | Weight: ≤27 lbs (12.2 kg) | Weight: ≤27 lbs (12.2 kg) | Identical |
| Display | 18.5" screen; aspect ratio of<br>16:9 with 1920 x 1080<br>resolution | 18.5" screen; aspect ratio of<br>16:9 with 1920 x 1080<br>resolution | Identical |
| Power Source | 100-240 VAC, 50/60 Hz, 3A<br>max<br>Fuse: (2) 5x20mm, 6.3A fast<br>acting, 250V | 100-240 VAC, 50/60 Hz, 3A<br>max<br>Fuse: (2) 5x20mm, 6.3A fast<br>acting, 250V | Identical |
| Biocompatibility | Biocompatible user contacting<br>surfaces | Biocompatible user contacting<br>surfaces | Identical |
| Software | version 2.1.2036 | version 2.1.2030 | Different.<br><br>Software update<br>allows for user to<br>control sound volume<br>during treatment.<br>Software V&V<br>demonstrates device<br>performs as intended. |
| Operating<br>System | Windows 10 | Windows 10 | Identical |
| Electrical<br>Safety & EMC<br>standards | Compliant with relevant IEC<br>standards for console and<br>ACLF power cord | Compliant with relevant IEC<br>standards for console and<br>ACLF power cord | Identical |

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### PERFORMANCE DATA 7

### 7.1 Nonclinical Testing

The following nonclinical data were provided to support the substantial equivalence of the subject device to the predicate device. In all instances, the subject device functioned as intended.

### Biocompatibility 7.1.1

Biocompatibility of the user-contacting components of the device was verified in accordance with ISO 10993-1.

#### 7.1.2 Electrical Safety

Electrical safety of the subject device was verified in accordance with IEC 60601-1.

#### 7.1.3 Software Verification and Validation Testing

Software verification and validation testing were conducted, and documentation was provided as recommended by FDA Guidance Content of Premarket Submissions Device Software Functions. A basic documentation level was used, as a failure or flaw of any device software function(s) would not present a hazardous situation with a probable risk of death or serious injury prior to the implementation of risk control measures.

#### 7.2 Clinical Testing

To support the device's indications for use, a comprehensive literature search was performed, and seven (7) unique clinical studies were identified that used the Ulthera System to improve the appearance of skin laxity on the abdomen, anterior arms, and posterior arms. These studies included a range of 54 to 113 subjects per region of the body (Table 2), 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.

### Table 2: Clinical Studies and Number of Subjects Evaluated to Support Expanded Indications for Use

| Device | Region of the<br>Body | Total Number of<br>Subjects Evaluated | Total Number of<br>Clinical Studies |
|-------------------|-----------------------|---------------------------------------|-------------------------------------|
| Ulthera<br>System | Abdomen | 54 | 3 |
| | Arms | 113 | 5 |

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), patient satisfaction surveys,

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and other validated clinical endpoints. From a safety perspective, there were no unexpected or severe adverse events (AEs), and all observed AEs resolved without long-term sequalae.

### CONCLUSIONS 8

The subject device has the same general intended use and principle of operation as the predicate device. The minor changes in device hardware and software do not raise different questions of safety or effectiveness and do not affect clinical functionality or performance specifications. These changes have been verified and validated through nonclinical performance testing, including biocompatibility, software verification and validation, and electrical safety. An analysis of clinical data from 167 subjects across seven (7) unique clinical studies has demonstrated the device is safe and effective in treating the additional regions of the body.

In summary, the nonclinical and clinical performance testing has demonstrated that the subject device operates as intended and that it is as safe and effective as the predicate for the proposed indications for use.