The SofMave System is indicated for use as a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles, lift the eyebrow, and lift lax submental (beneath the chin) and neck tissue; which can also affect the appearance of lax tissue in the submental and neck region for subjects aged 22 and older. The SofWave System is also indicated for short-term improvement in the appearance of cellulite.

The Pure Impact module is indicated to be used for:

· Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen.

· Strengthening, toning and firming of buttocks and thighs.

Device Description

The SofMave System is an ultrasound system intended for aesthetic purposes. The system generates high frequency ultrasonic pulses that elevate the temperature in the dermis layer and cause controlled isolated areas of thermal damage.

The SofMave System consists of three main functional components: 1) console; 2) applicator; and 3) Electrical Muscle Stimulation (EMS) Module (Pure Impact). The console includes the power sources, cooling unit, electrical components, IoT, BLE, and the user interface. The applicator is comprised of an array of ultrasonic transducers that emit continuous acoustic waves at 10-12 MHz and an active cooling element that is used to cool the skin area in contact with the applicator. The applicator is connected by a flexible cable to the console. The EMS module is wirelessly connected to and controlled by the SofWave console. It functions independently from the ultrasound system. The user selects either the ultrasound treatment or the EMS treatment, but not both, at the beginning of the treatment.

AI/ML Overview

The provided text focuses on the 510(k) submission for the SofWave System, specifically for the addition of a "Smooth applicator" and its use in "short-term improvement in the appearance of cellulite." The core of the submission is to demonstrate substantial equivalence to a predicate device (K232455), which fundamentally relies on showing that the changes introduced (the Smooth applicator) do not raise new questions of safety or effectiveness.

It is important to note that the provided text does not detail specific, quantified acceptance criteria for the device's performance in terms of achieving a certain level of improvement in cellulite appearance, nor does it present a direct comparative effectiveness study (MRMC) against human readers or specify an "effect size of how much human readers improve with AI vs without AI assistance." This is because the device itself is a treatment device (Focused Ultrasound Stimulator System for Aesthetic Use), not an AI-based diagnostic tool that assists human readers.

Instead, the "performance data" section describes the studies conducted to demonstrate that the device (with the new applicator) functions safely and as expected, aligning with the predicate device's established performance. The study described is a clinical study for safety and effectiveness related to cellulite appearance, which is a clinical outcome rather than an algorithm's performance in a diagnostic task.

Given this context, I will extract and present the information as best as possible, interpreting "acceptance criteria" and "device performance" in the context of a treatment device demonstrating substantial equivalence, rather than a diagnostic AI.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a treatment device, the "acceptance criteria" are implied by the FDA's "Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use" (2011) and the expectation of demonstrating substantial equivalence to a predicate device. The performance is assessed in terms of safety and the expected aesthetic improvement, similar to the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Safety: Device-related adverse events are minimal and mild.	Throughout the study, there was only one device-related adverse event reported, which was mild in severity. No serious or unanticipated adverse event was reported during the study.
Effectiveness (Cellulite Appearance): Demonstrates improvement in cellulite appearance, consistent with predicate device.	Blinded Reviewer Assessment: The blinded reviewers correctly identified the post-treatment images for 92% of the subjects.
	Pain Level: The mean pain level was 4.26 (moderate pain). No subjects withdrew from the study due to discomfort or pain.
	Consistency with Predicate: Based on a literature review, the study results were consistent with the predicate device.
Functional Bench Testing: Addition of Smooth applicator does not negatively affect device performance.	Functional bench testing was conducted to verify that the addition of the Smooth applicator did not affect the device performance (reported as "demonstrated that the device performs as intended"). Acoustic mapping testing showed very similar acoustic parameters for the Smooth and Lift applicators. Thermal coagulation for each PZT is expected to be the same, demonstrated in performance testing.
Biocompatibility: Patient-contacting components are biocompatible.	Biocompatibility of the patient-contacting components of the device was established in accordance with ISO 10993.
Software Verification and Validation: Software performs as intended.	Software verification and validation was performed, and demonstrated that the software performs as intended.
Electrical Safety and EMC: Complies with relevant standards.	Electrical Safety and Electromagnetic Compatibility was established in accordance with IEC 60601-1-2, IEC 60601-1, IEC 60601-1-6, IEC 60601-2-10, and IEC 60601-2-62.
In vivo (Animal) Safety & Effectiveness: Thermal effects and coagulation zones are as expected.	The preclinical, acute, in vivo study using a porcine model demonstrated that the thermal effects and the coagulation zones induced by SofWave Smooth applicator are as expected.

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

Test Set Sample Size: 60 subjects were enrolled and treated in the clinical study.
Data Provenance:
- Country of Origin: The clinical study was conducted at 5 sites in the United States.
- Retrospective or Prospective: The clinical study for cellulite appearance was prospective, as subjects received treatments and were followed up (baseline, 3-month follow-up). The animal model study was also prospective.

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

The text describes that "blinded independent reviewers" assessed photographs to identify pre-treatment vs. post-treatment images and grade improvement.

Number of experts: Not specified explicitly. It states "blinded independent reviewers" (plural).
Qualifications of experts: Not specified beyond being "independent" and "blinded." Their specific medical or aesthetic qualifications (e.g., dermatologists, plastic surgeons, radiologists) are not detailed.

4. Adjudication method for the test set

The text does not explicitly describe an adjudication method (like 2+1 or 3+1 consensus) for the "blinded independent reviewers'" assessments. It just states they "assessed" and "correctly identified" images, implying a single assessment per reviewer or the aggregate result of their assessments.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No, an MRMC comparative effectiveness study was not conducted in the traditional sense of evaluating an AI's impact on human reader diagnostic performance. The SofWave System is a treatment device, not a diagnostic AI. The clinical study aimed to demonstrate the device's safety and effectiveness in treating cellulite, not to improve human diagnostic accuracy.
Effect Size of Human Readers with/without AI: Not applicable for this device and study.

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

Standalone Performance: Not applicable/not performed in the context of an AI algorithm's diagnostic performance. The "device performance" was evaluated in terms of its physical outputs (acoustic parameters, thermal effects) and its clinical outcomes when used by an operator (as a therapy).

7. The type of ground truth used

The "ground truth" for the clinical study on cellulite improvement was established through:

Expert Consensus/Blinded Reviewer Assessment: Serial clinical photographs assessed by blinded independent reviewers to identify pre-treatment vs. post-treatment images and grade improvement using established scales (Cellulite Severity Scale - CSS, Global Aesthetic Improvement Scale - GAIS, Laxity Scale - LS). This is a form of expert consensus on photographic evidence.
Outcomes Data: Evaluation of Adverse Events (AEs) via physician examination.
Pathology/Histology (for animal study): For the animal model, the ground truth for the efficacy of the thermal effects was histological tissue thermal effects and coagulative zones.

8. The sample size for the training set

The text relates to a 510(k) submission for a physical medical device (ultrasound system), not for an AI algorithm that requires a "training set" in the machine learning sense. Therefore, a sample size for a training set is not applicable and not mentioned.

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

As explained above, there is no "training set" in the context of an AI algorithm here. The ground truth for the device's development and validation involved engineering specifications, bench testing, animal studies, and limited human clinical data to demonstrate physical and clinical performance, but not in the format of a machine learning training dataset.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for 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 in blue, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below.

May 30, 2024

Sofwave Medical Ltd. % Janice Hogan Regulatory Counsel Hogan Lovells US LLP 1735 Market Street Suite 2300 Philadelphia, Pennsylvania 19103

Re: K240687

Trade/Device Name: SofWave System Regulation Number: 21 CFR 878.4590 Regulation Name: Focused Ultrasound Stimulator System For Aesthetic Use Regulatory Class: Class II Product Code: OHV, NGX Dated: March 12, 2024 Received: March 12, 2024

Dear Janice Hogan:

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/cdrb/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.

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).

Sincerely,

Digitally signed by Long H. Chen
Long H. Chen -S-5
Date: 2024.05.30 08:02:13 -04'00'

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices

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Enclosure

Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

Submission Number (if known)

K240687

Device Name

SofWave System

Indications for Use (Describe)

The Pure Impact module is indicated to be used for:

· Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen.

· Strengthening, toning and firming of buttocks and thighs.

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)

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510(K) SUMMARY

Sofwave Medical's SofWave System

Submitter's Name, Address, Telephone Number, Contact Person, and Date Prepared

Sofwave Medical Ltd. 1 Ha-Otsma St. Yokneam Ilit, Israel 2069200

Submission Correspondent:

Janice M. Hogan Hogan Lovells US LLP janice.hogan@hoganlovells.com (267) 675-4611

Date Prepared: March 12, 2024

Name of Device:

SofWave System

Classification Name:

21 CFR 878.4590 (Focused Ultrasound Stimulator System for Aesthetic Use), Class II, product code OHV

21 CFR 890.5850 (Powered Muscle Stimulator), Class II, product code NGX

Predicate Devices

Sofwave Medical's SofWave System (K232455) (Predicate Device)

Intended Use / Indications for Use

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The Pure Impact module is indicated to be used for:

. Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen.
. Strengthening, toning and firming of buttocks and thighs.

Technological Characteristics

The SofWave System is an ultrasound system intended for aesthetic purposes. The system generates high frequency ultrasonic pulses that elevate the temperature in the dermis layer and cause controlled isolated areas of thermal damage.

Comparison of Technological Characteristics with the Predicate Device

The SofWave System has very similar technological characteristics compared to the predicate device. The primary modification is the addition of a larger applicator (Smooth applicator) to the existing applicators (Lift and Precise). This additional applicator is designed to offer better user treatment flexibility.

The Smooth applicator dimensions and tips size, technology and principles of operations are the same as the cleared Lift applicator. There are no changes to the materials used to manufacture the new applicator. While the Smooth applicator has a larger PZT area is 2 mm x 5 mm (10 mm²), compared to the existing Lift applicator PZT area of 1 mm x 5 mm (5 mm²), this difference in PZT size does not raise new questions of safety or effectiveness. With the change in the treatment area of each PZT, the maximum energy intensity (total power/area) is reduced compared to the predicate. This is further demonstrated by the acoustic mapping testing, which showed very similar acoustic parameters for the Smooth and Lift applicators. In addition, the frequency (10-12 MHz) and thermal coagulation depth (1-2 mm) are also the same for both applicators. Therefore, the thermal coagulation for each PZT is expected to be the same, which is in fact demonstrated in the performance testing, including bench, electrical, biocompatibility, software, animal, and clinical testing. The test results demonstrated that the device with the additional Smooth applicator performs similarly as the predicate device.

Thus, the subject SofWave device has similar technological characteristics as its predicate device.

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	Sofwave Medical's SofWaveSystem	Sofwave Medical's SofWaveSystem (K232455)
	Subject Device	(Predicate Device)
SofWave Module
CFR Regulation	21 CFR 878.4590	21 CFR 878.4590
Product Code	OHV	OHV
Intended Use	The SofWave System is indicatedfor use as a non-invasivedermatological aesthetictreatment to improve facial linesand wrinkles, lift the eyebrow, andlift lax submental (beneath thechin) and neck tissue; which canalso affect the appearance of laxtissue in the submental and neckregions for subjects aged 22 andolder. The SofWave System isalso intended for short-termimprovement in the appearanceof cellulite.	The SofWave System is indicatedfor use as a non-invasivedermatological aesthetictreatment to improve facial linesand wrinkles, lift the eyebrow, andlift lax submental (beneath thechin) and neck tissue; which canalso affect the appearance of laxtissue in the submental and neckregions for subjects aged 22 andolder. The SofWave System isalso intended for short-termimprovement in the appearance ofcellulite.
Device Technology	High intensity, non-focusedultrasound	High intensity, non-focusedultrasound
System components	Console that includes thepower sources, electricalcomponents and userinterface (touchscreen)Handpiece (Lift, Precise,Smooth)	Console that includes thepower sources, electricalcomponents and userinterface (touchscreen)Handpiece (Lift, Precise)
Energy Type	High Intensity non-focusedUltrasound	High Intensity non-focusedUltrasound
Energy Delivered PerChannel	3-5 Joule per PZT (Lift andPrecise applicators)2.6-7 Joule per PZT (Smoothapplicator)	3-5 Joule per PZT (Lift andPrecise applicators)
Epidermal Impact	Non-invasive	Non-invasive
Treatment Area Width	Precise applicator: 15 mm2Lift applicator: 35 mm2Smooth applicator: 70 mm2	Precise applicator: 15 mm2Lift applicator: 35 mm2

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	Sofwave Medical's SofWaveSystem	Sofwave Medical's SofWaveSystem (K232455)
	Subject Device	(Predicate Device)

User Interface	LCD Touch Screen Graphic UserInterface	LCD Touch Screen Graphic UserInterface
Pure Impact Module
Classification Name	Powered muscle stimulator	Powered muscle stimulator
Product Code	NGX	NGX
Regulation Number	21 CFR 890.5850	21 CFR 890.5850
Panel	Physical Medicine	Physical Medicine
Class	Class II	Class II
Indication for use	indicated to be used for:Improvement of abdominaltone, for strengthening of theabdominal muscles, fordevelopment of firmerabdomen.Strengthening, toning andfirming of buttocks and thighs.	indicated to be used for:Improvement of abdominaltone, for strengthening of theabdominal muscles, fordevelopment of firmerabdomen.Strengthening, toning andfirming of buttocks and thighs.
Target population	It is to be used by adults only.	It is to be used by adults only.
Power source	Console Power source: 100-240AC, 50/60HzRechargeable Lithium IonPolymer Battery Pack 3.7 VNominal Voltage: 3.7VNominal Capacity: 600mA	Console Power source: 100-240AC, 50/60HzRechargeable Lithium IonPolymer Battery Pack 3.7 VNominal Voltage: 3.7VNominal Capacity: 600mA
Patient LeakageCurrent - NormalCondition	Normal condition = less than100µA	Normal condition = less than100µA
Components	Console, 8 stimulation modules(up to 4 units working in parallel),Maximum of 16 electrode padsper treatment	Console, 8 stimulation modules(up to 4 units working in parallel),Maximum of 16 electrode padsper treatment
Display	15" LCD	15" LCD
Number of OutputChannels	Maximum of 4 channels pertreatment	Maximum of 4 channels pertreatment
	Sofwave Medical's SofWaveSystemSubject Device	Sofwave Medical's SofWaveSystem (K232455)(Predicate Device)
Method of ChannelIsolation	Separate units for pulsegeneration (wireless units). Linepower is NA	Separate units for pulsegeneration (wireless units). Linepower is NA
Regulated Current orRegulated Voltage	Regulated current (all channels)	Regulated current (all channels)
Software/Firmware/MicroprocessorsControls?	Yes	Yes
Automatic OverloadTrip?	Yes	Yes
Automatic No-LoadTrip	Yes	Yes
Automatic Shut off?	Yes	Yes
Patient OverrideControl?	Yes	Yes
Indicator Display:On/Off Status?	Yes	Yes
Low Battery?	Yes	Yes
Voltage/Current Level?	Yes (Energy level)	Yes (Energy level)
Timer Range (minutes)	Up to 60 minutes	Up to 60 minutes
Compliance withVoluntary Standards?	Yes IEC 60601-1, IEC 60601-1-2,IEC60601-2-10, and ISO14971	Yes IEC 60601-1, IEC 60601-1-2,IEC60601-2-10, and ISO14971
Compliance With 21CFR 898	Yes, the electrode cable cannever be plugged in the ACsocket, not even accidentally	Yes, the electrode cable cannever be plugged in the ACsocket, not even accidentally
Housing Material andconstruction	PCABS510 for console covers &end point shells	PCABS510 for console covers &end point shells
Operating Temperature	Temperature: 5°C to +30°CRelative Humidity: 30% to 70 %	Temperature: 5°C to +30°CRelative Humidity: 30% to 70 %
Transport and storageenvironment	Temperature: +5°C to +30°CRelative Humidity: 30% to 70%(noncondensing)	Temperature: +5°C to +30°CRelative Humidity: 30% to 70%(noncondensing)

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Performance Data

The following nonclinical performance testing has been conducted to support the substantial equivalence of the SofMave System to its predicate device, consistent with FDA's "Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use" (2011). In all instances, the SofWave System functioned as intended.

Biocompatibility of the patient-contacting components of the device was established in accordance with ISO 10993
. Software verification and validation was performed, and demonstrated that the software performs as intended
. Electrical Safety and Electromagnetic Compatibility was established in accordance with IEC 60601-1-2, IEC 60601-1, IEC 60601-1-6, IEC 60601-2-10, and IEC 60601-2-62
. Functional bench testing was conducted to verify that the addition of the Smooth applicator did not affect the device performance
. In vivo testing in an animal model was performed to evaluate and establish the safety and effectiveness of the subject device The preclinical, acute, in vivo study using a porcine model was designed to assess the histological tissue thermal effects and coagulative zones created by the SofWave system while using the Smooth applicator across a range of treatment settings. The animal study demonstrated that the thermal effects and the coagulation zones induced by SofWave Smooth applicator are as expected.

While clinical study is not required to establish substantial equivalence, the company has conducted a clinical study to demonstrate the safety and effectiveness of the device when using the new Smooth applicator for the non-invasive dermatological aesthetic improvement in cellulite appearance. A total of 60 subjects were enrolled and treated at 5 sites in the United States.

Eligible patients received 2 treatments (2-4 weeks apart) using the Smooth applicator of the subject SoftWave system on one or both legs. Serial clinical photographs were collected under standardized conditions before treatment (baseline) and at the 3-month follow-up visits. Photographs were assessed by blinded independent reviewers to identify pre-treatment images when compared to post treatment images and to grade the pre-treatment and post-treatment images using the Cellulite Severity Scale (CSS). Improvement was also evaluated using the Global Aesthetic Improvement Scale (GAIS) and Laxity Scale (LS). Safety assessments included evaluation of AEs via physician examination during and after the treatment. The blinded reviewers correctly identified the post treatment images for 92% of the subjects. Throughout the study, there was only one device-related adverse event reported, which was mild in severity. No serious or unanticipated adverse event was reported during the study. The mean pain level was 4.26 (moderate pain). No subjects withdrew from the study due to discomfort or pain. Based on a literature review, the study results were consistent with the predicate device.

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Conclusion

SofWave has the same intended use and indications, and similar technological characteristics as the predicate device. The minor technological differences between the subject and the predicate device do not raise different questions of safety or effectiveness. Performance testing of the device has demonstrated that the device performs as intended and thus is substantially equivalent to its predicate.

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.