(89 days)
Not Found
No.
The document indicates that the device operates based on focused ultrasound energy, not AI models. Details provided describe electrical safety, software validation, usability, and cybersecurity testing, with no mention of AI, machine learning, or deep neural networks.
Yes
The device is described as applying focused ultrasound energy to achieve temporary changes in the physical appearance of the skin and is indicated for non-invasive dermatological aesthetic treatments to lift, improve lines, and improve skin laxity, all of which fall under typical therapeutic applications in dermatology.
No
The device is intended for aesthetic treatments such as lifting and improving the appearance of skin. While it utilizes ultrasound for visualization to ensure proper coupling and depth of treatment, this visualization is to aid the therapeutic application, not to diagnose a medical condition.
No
The device is not a software-only medical device because the device description explicitly states it consists of a "Control Unit (with system software), a handpiece with cable, and interchangeable transducers," clearly indicating physical hardware components beyond just software. The entire system applies focused ultrasound energy, which is a physical action requiring hardware. Additionally, the performance studies include electrical safety and usability testing related to the physical operation of the device and "new SEE.PLAN.TREAT.® mode of the system", not just software.
No.
This device is an aesthetic treatment system that uses focused ultrasound energy to improve the appearance of the skin and does not perform in vitro examination of specimens derived from the human body.
N/A
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, 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
Product codes
OHV, IYO
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic visualization
Anatomical Site
Eyebrow, submental (beneath the chin), neck, décolleté, abdomen, anterior arms, posterior arms.
Indicated Patient Age Range
Adult patient population.
Intended User / Care Setting
Trained medical professional.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical data were provided to support the substantial equivalence of the subject device to the predicate device. The subject device functioned as intended in all instances.
Clinical functionality or performance specifications are not affected by the minor software and hardware differences. These changes have been verified and tested.
- Electrical Safety: Verified in accordance with IEC 60601-1 and IEC 60601-1-2.
- Software Verification and Validation Testing: Conducted as recommended by FDA Guidance Content of Premarket Submissions Device Software Functions. A basic documentation level was used.
- Usability: Testing was conducted in accordance with IEC 62366-1 and FDA Guidance, "Applying Human Factors and Usability Engineering to Medical Devices." Focused on the new SEE.PLAN.TREAT.® mode. Demonstrated clinicians were able to use the device in a representative environment and use conditions. No new risks identified.
- Cybersecurity: Testing was conducted as recommended by FDA guidance Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4590 Focused ultrasound stimulator system for aesthetic use.
(a)
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.(b)
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.
FDA 510(k) Clearance Letter - Ulthera System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 13, 2025
Ulthera Inc.
Christopher Lefancheck
Senior Regulatory Affairs Specialist
6501 Six Forks Road
Raleigh, North Carolina 27615
Re: K250418
Trade/Device Name: Ulthera System (UC-1 Control Unit PRIME Model 2.1)
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 13, 2025
Received: February 13, 2025
Dear Christopher Lefancheck:
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.
Page 2
K250418 - Christopher Lefancheck Page 2
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" (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 QS 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 (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 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 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-
Page 3
K250418 - Christopher Lefancheck Page 3
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
James H. Jang -S (Digitally signed by James H. Jang -S Date: 2025.05.13 17:34:42 -04'00')
James Jang, 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
Page 4
FORM FDA 3881 (8/23) Page 1 of 1
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): K250418
Device Name: Ulthera System (UC-1 Control Unit PRIME Model 2.1)
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)
☒ 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
PRAStaff@fda.hhs.gov
"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."
Page 5
510(k) Summary
1 APPLICANT
Company's Name: Ulthera, Inc.
Company's Address: 6501 Six Forks Road
Raleigh, NC 27615
Telephone: 919.215.4879
Contact Person: Christopher Lefancheck, Sr. Regulatory Affairs Specialist
Date Prepared: May 9th, 2025
2 DEVICE
Device Name: Ulthera System (UC-1 Control Unit PRIME Model 2.1)
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
- Content of Premarket Submissions for Software Contained in Medical Devices.
- Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
3 PREDICATE DEVICE
Ulthera System (UC-1 Control Unit PRIME), Ulthera, Inc., K233996
Ulthera System (UC-1 Control Unit PRIME), Ulthera, Inc., K243035
Page 6
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, 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
Page 7
6 SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
The purpose of this 510(k) notification relates to changes to the software of the Ulthera System to allow for wireless connectivity and implement the new treatment planning mode SEE.PLAN.TREAT.®. 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.
- 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 software and hardware differences between the subject and predicate systems (see Table 1) do not affect clinical functionality or performance specifications of the system and have been verified and tested.
Table 1: Substantial Equivalence Table Comparing Subject & Predicate Device
| Ulthera System (Subject Device) | Ulthera System K233996 (Predicate) | Ulthera System K243035 (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. | The Ulthera System is intended to apply focused ultrasound energy to the body to achieve temporary changes in the physical appearance of the skin. |
| 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, and posterior arms | 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 | 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 |
Page 8
| Ulthera System (Subject Device) | Ulthera System K233996 (Predicate) | Ulthera System K243035 (Predicate) | |
|---|---|---|---|
| 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 | 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 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 | |||
| User Population | Treatment of adult patient population by trained medical professional | Treatment of adult patient population by trained medical professional | Treatment of adult patient population by trained medical professional |
| Main System Components | • Control console | ||
| • Handpiece | |||
| • Transducers | • Control console | ||
| • Handpiece | |||
| • Transducers | • Control console | ||
| • Handpiece | |||
| • Transducers | |||
| Additional Components Required for Operation | • ACLF Power Cord with pigtail adapter | ||
| • Wibu USB Access Key | • ACLF Power Cord with pigtail adapter | ||
| • CrypKey USB Access Key | • ACLF Power Cord with pigtail adapter | ||
| • CrypKey USB Access Key | |||
| Console Dimensions | Height: |