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 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.

AI/ML Overview

The provided document is a 510(k) summary for the Ulthera System, seeking clearance for expanded indications for aesthetic use on the abdomen, anterior arms, and posterior arms.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the information provided:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly state quantitative acceptance criteria in a typical "numeric threshold" format. Instead, the acceptance is based on demonstrating "clinically significant skin improvement" and an acceptable safety profile, comparable to the predicate device. The performance is reported qualitatively based on the outcomes of the reviewed clinical studies.

Acceptance Criteria (Implicit)	Reported Device Performance (Summary from Document)
Safety	"From a safety perspective, there were no unexpected or severe adverse events (AEs), and all observed AEs resolved without long-term sequalae."
Effectiveness (Abdomen)	Three clinical studies (n=54 subjects) 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, and other validated clinical endpoints."
Effectiveness (Arms)	Five clinical studies (n=113 subjects) 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, and other validated clinical endpoints."
Functionality (Non-clinical)	"In all instances, the subject device functioned as intended." (Biocompatibility, Electrical Safety, Software V&V)
Substantial Equivalence	The 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."

2. Sample sizes used for the test set and the data provenance

Test Set Sample Size: The document does not describe a traditional "test set" in the context of an AI/algorithm performance study. Instead, it references a literature search of existing clinical studies supporting the expanded indications.
- Abdomen: 54 subjects across 3 unique clinical studies.
- Arms (anterior and posterior): 113 subjects across 5 unique clinical studies.
- Total: 167 subjects across 7 unique clinical studies (some studies likely included both abdomen and arms, though this is not explicitly broken down for unique subjects per region).
Data Provenance: The document states "a comprehensive literature search was performed." This implies the data were
- Retrospective: The studies were already completed and published, not prospectively designed for this 510(k) submission.
- Country of Origin: Not specified in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The concept of "experts establishing ground truth" as typically seen in AI performance studies (e.g., radiologists annotating images) is not directly applicable here. The "ground truth" for the effectiveness of the Ulthera system is based on:

Blinded clinician photographic assessment: This indicates that medical professionals (clinicians) evaluated photographic evidence, likely pre- and post-treatment, without knowing which was which. The number and qualifications of these clinicians are not specified.
Physician Global Aesthetic Improvement Scores (GAIS): Physicians assessed improvements. The number and qualifications of these physicians are not specified.
Subject Global Aesthetic Improvement Scores (GAIS): Patients themselves provided self-assessments.

4. Adjudication method for the test set

The document does not detail an adjudication method for the clinical outcomes. While "blinded clinician photographic assessment" and "physician GAIS" suggest clinical evaluation, there's no mention of how discrepancies between multiple assessors were resolved (e.g., 2+1, 3+1). If multiple clinicians assessed the same case, their consensus or a defined adjudication process is not described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not conducted. This submission is for a device that delivers energy for aesthetic treatment, not an AI diagnostic algorithm that assists human readers in reading cases. The clinical data reported focuses on the device's direct effect on patients, not on how an AI component improves human interpretation.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

The Ulthera System is a therapeutic device with an imaging component. It is not an AI algorithm, and therefore, a standalone performance study in the context of an AI system would not apply. The device's imaging function allows visualization for proper coupling and depth confirmation, but it's not a diagnostic AI system with an "algorithm only" performance metric. The "software verification and validation testing" mentioned is for the device's operational software, not an AI diagnostic algorithm.

7. The type of ground truth used

The ground truth for effectiveness was primarily clinical and subjective-to-observer:

Blinded clinician photographic assessment: Implies visual expert assessment.
Physician Global Aesthetic Improvement Scores (GAIS): Expert (physician) subjective assessment.
Subject Global Aesthetic Improvement Scores (GAIS): Patient subjective assessment.
Patient satisfaction surveys: Patient subjective assessment.
Other validated clinical endpoints: While vaguely described, this suggests other established clinical metrics were used.

No mention of pathology (biopsy) or long-term outcomes data beyond 180 days is provided as primary ground truth.

8. The sample size for the training set

The concept of a "training set" is not applicable here as the submission is for a medical device (focused ultrasound system) with new anatomical indications, not a machine learning model developed with a training set. The existing clinical studies were used as evidence to support the expanded indications, analogous to a validation set rather than a training set for an AI/ML model.

9. How the ground truth for the training set was established

As there is no "training set" for an AI/ML model in this submission, this question is not applicable.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

· 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 RoadRaleigh, NC 27615
Telephone:	919.215.4879
Contact Person:	Scott Jewett, Regulatory Affairs Manager
Date Prepared:	19 February 2025
2 DEVICE
Device Name:	Ulthera System
Classification Name:	Focused Ultrasound Stimulator System for Aesthetic Use21 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 UseMarketing Clearance of Diagnostic Ultrasound Systems andTransducersContent of Premarket Submissions for Software Contained inMedical Devices

3 PREDICATE DEVICE

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

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DEVICE DESCRIPTION 4

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

. 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(Subject Device)	Ulthera SystemK233996(Predicate)	Similarities andsignificantdifferences to thepredicate
Intended Use	The Ulthera System isintended to apply focusedultrasound energy to the bodyto achieve temporary changesin the physical appearance ofthe skin.	The Ulthera System isintended to apply focusedultrasound energy to the bodyto achieve temporary changesin the physical appearance ofthe skin.	Identical
Indications forUse	The Ulthera® System isindicated for use as a non-invasive dermatologicalaesthetic treatment to:lift the eyebrow lift lax submental(beneath the chin)and neck tissue;which can also affectthe appearance of laxtissue in thesubmental and neckregions improve lines andwrinkles of thedécolleté Improve theappearance of skinlaxity on theabdomen, anteriorarms, and posteriorarms The Ulthera® System inconjunction with the Ulthera®DeepSEE transducer allowsfor ultrasonic visualization ofdepths up to 8 mm below thesurface of the skin. Theindicated use of the imaging isto visualize the dermal andsubdermal layers of tissue to:ensure propercoupling of thetransducer to the skin confirm appropriatedepth of treatmentsuch as to avoid bone	The Ulthera® System isindicated for use as a non-invasive dermatologicalaesthetic treatment to:lift the eyebrow lift lax submental(beneath the chin)and neck tissue;which can also affectthe appearance of laxtissue in thesubmental and neckregions improve lines andwrinkles of thedécolleté. The Ulthera® System inconjunction with the Ulthera®DeepSEE transducer allowsfor ultrasonic visualization ofdepths up to 8 mm below thesurface of the skin. Theindicated use of the imaging isto visualize the dermal andsubdermal layers of tissue to:ensure propercoupling of thetransducer to the skin confirm appropriatedepth of treatmentsuch as to avoid bone	DifferentAdditionalindications added forthe abdomen, anteriorarms, and posteriorarms. Clinical datahave been providedto demonstrate thesafety andeffectiveness of thedevice for theexpanded indicationsand support theexpansion of thesubject device'sindications for use.
User Population	Treatment of adult patientpopulation by trained medicalprofessional	Treatment of adult patientpopulation by trained medicalprofessional	Identical
	Ulthera System(Subject Device)	Ulthera SystemK233996(Predicate)	Similarities andsignificantdifferences to thepredicate
Main SystemComponents	• Control console• Handpiece• Transducers	• Control console• Handpiece• Transducers	Identical
AdditionalComponentsRequired forOperation	• ACLF Power Cord withpigtail adapter• USB Access Key	• ACLF Power Cord withpigtail adapter• USB Access Key	Identical
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
Weight	Weight: ≤27 lbs (12.2 kg)	Weight: ≤27 lbs (12.2 kg)	Identical
Display	18.5" screen; aspect ratio of16:9 with 1920 x 1080resolution	18.5" screen; aspect ratio of16:9 with 1920 x 1080resolution	Identical
Power Source	100-240 VAC, 50/60 Hz, 3AmaxFuse: (2) 5x20mm, 6.3A fastacting, 250V	100-240 VAC, 50/60 Hz, 3AmaxFuse: (2) 5x20mm, 6.3A fastacting, 250V	Identical
Biocompatibility	Biocompatible user contactingsurfaces	Biocompatible user contactingsurfaces	Identical
Software	version 2.1.2036	version 2.1.2030	Different.Software updateallows for user tocontrol sound volumeduring treatment.Software V&Vdemonstrates deviceperforms as intended.
OperatingSystem	Windows 10	Windows 10	Identical
ElectricalSafety & EMCstandards	Compliant with relevant IECstandards for console andACLF power cord	Compliant with relevant IECstandards for console andACLF 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 theBody	Total Number ofSubjects Evaluated	Total Number ofClinical Studies
UltheraSystem	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.

Regulation Number and Section

§ 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.