SofWave System

K232455 · Sofwave Medical, Ltd. · OHV · Dec 14, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K232455
• Device Name: SofWave System
• Applicant: Sofwave Medical, Ltd.
• Product Code: OHV · General, Plastic Surgery
• Decision Date: Dec 14, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4590
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SofWave 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 Story

SofWave System combines ultrasound and electrical muscle stimulation (EMS). Ultrasound module uses high-frequency ultrasonic pulses to heat dermis, causing controlled thermal damage for aesthetic skin tightening. Pure Impact module uses wireless EMS to deliver electrical impulses via skin electrodes to contract muscles for toning/strengthening. System comprises console (power, cooling, UI) and applicators. Operated by clinicians in aesthetic settings. User selects either ultrasound or EMS mode at start. Output includes thermal energy (ultrasound) or rhythmic muscle contractions (EMS). Benefits include improved skin appearance and muscle tone. Wireless EMS module functions independently from ultrasound system; console controls all functions via touchscreen.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility (ISO 10993-1), software verification/validation, electrical safety/EMC (IEC 60601 series), functional bench testing, and usability validation. No clinical data presented.

Technological Characteristics

Ultrasound: High-frequency non-focused ultrasound, 3-5 J/PZT (6-10 J/cm2). EMS: Symmetrical biphasic square wave, 1-100Hz, max 200mA pp. Materials: PCABS510 housing. Connectivity: Wireless EMS module to console. Standards: IEC 60601-1, 60601-1-2, 60601-2-10, ISO 14971. Cooling: Active cooling element in ultrasound applicator.

Indications for Use

Indicated for adults aged 22+ for non-invasive aesthetic treatment of facial lines/wrinkles, eyebrow lifting, and submental/neck tissue laxity; short-term cellulite improvement. Pure Impact module indicated for abdominal tone improvement, strengthening abdominal muscles, and strengthening/toning/firming buttocks and thighs.

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

• Sofwave Medical's SofWave System (K230820)
• Johari Digital Healthcare Limited's truSculpt flex (K212866)

Reference Devices

• DJO LLC's Compex Wireless USA (K143551)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 14, 2023

Sofwave Medical Ltd. % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia, Pennsylvania 19103

Re: K232455

Trade/Device Name: SofWave System Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX, OHV Dated: November 17, 2023 Received: November 17, 2023

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/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"

{1}------------------------------------------------

(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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Heather L. Dean -S

Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices

{2}------------------------------------------------

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

Enclosure

{3}------------------------------------------------

# Indications for Use

510(k) Number (if known) K232455

Device Name SofWave System

#### Indications for Use (Describe)

The SofWave 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.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

#### 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."

{4}------------------------------------------------

# 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 [e-mail] [phone]

Date Prepared: December 12, 2023

#### 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 (K230820) (Predicate Device)

Johari Digital Healthcare Limited's truSculpt flex (K212866) (Predicate Device)

DJO LLC's Compex Wireless USA (K143551) (Reference Device)

#### Intended Use / Indications for Use

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.

{5}------------------------------------------------

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. The SofWave System consists of two main functional components: 1) the console and 2) the applicator. The console includes the power sources, cooling unit, electrical components, IoT, and the user interface. The applicator is comprised of an array of ultrasonic transducers that emit continuous acoustic waves 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 subject device of this 510(k) adds an EMS module ("Pure Impact") to the previously cleared SofWave ultrasound system (K230820). The EMS module is wirelessly connected to and controlled by the SoftWave console. It functions independently from the existing ultrasound system. The user selects either the ultrasound treatment or the EMS treatment, but not both, at the beginning of the treatment.

# Comparison of Technological Characteristics with the Predicate Device

The SofWave System has similar technological characteristics compared to the predicate devices. The subject SofWave device is almost identical to the previously SofMave device that was cleared in K230820, except minor hardware changes, which do not significantly affect clinical functionality or performance specifications of the device, and have been verified and tested. The treatment parameters and energy specifications of the device remain identical to that cleared in K230820 for the ultrasound module. The purpose of this 510(k) notification is to add a wirelessly connected EMS module (Pure Impact) to the existing system. Importantly, the inclusion of the Pure Impact module does not affect the performance of the SofWave module; nor does it require any significant hardware modifications to the SofWave console or the applicator.

The Pure Impact module has similar technological characteristics as the truSculpt flex predicate (K212866). Both devices are electrical muscle stimulators that generate electrical impulses, which are delivered through electrodes on the skin in direct proximity to the muscles to be stimulated. Both devices contract muscles rhythmically to achieve the intended use of strengthening, firming, and toning the muscles of the abdomen, thighs, and buttocks.

Both Pure Impact and truSculpt flex console with a touchscreen control panel and stimulation electrodes. For both devices, all system functions are controlled through the console. While there are minor differences in the connection between console and electrodes, these differences do not raise new questions of safety or effectiveness. For both devices, the same types of safety questions arise, i.e., whether the devices can safely stimulate the muscle and not result in injury to the patient. Also, the same types of efficacy questions arise, i.e., whether the devices can effectively achieve the intended use of strengthening, firming, and toning the muscle.

{6}------------------------------------------------

Furthermore, wireless stimulation of muscles has been cleared by FDA for other devices with similar intended use, such as the Compex Wireless reference device (K143551).

| | Subject device | Predicate Device K230820 |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product | SofWave (SofWave Module) | SofWave |
| Regulation | 21 CFR 878.4590 | 21 CFR 878.4590 |
| Product code | OHV | OHV |
| Indications | The SofWave System is indicated for<br>use as a non-invasive dermatological<br>aesthetic treatment to improve facial<br>lines and wrinkles, lift the eyebrow,<br>and lift lax submental (beneath the<br>chin) and neck tissue; which can also<br>affect the appearance of lax tissue in<br>the submental and neck regions for<br>subjects aged 22 and older. The<br>SofWave System is also intended for<br>short-term improvement in the<br>appearance of cellulite. | The SofWave System is indicated for<br>use as a non-invasive dermatological<br>aesthetic treatment to improve facial<br>lines and wrinkles, lift the eyebrow,<br>and lift lax submental (beneath the<br>chin) and neck tissue; which can also<br>affect the appearance of lax tissue in<br>the submental and neck regions for<br>subjects aged 22 and older. The<br>SofWave System is also intended for<br>short-term improvement in the<br>appearance of cellulite. |
| Technology | High Intensity non-focused<br>Ultrasound | High Intensity non-focused<br>Ultrasound |
| System components | Console that includes the power sources, electrical components and user interface (touchscreen) Handpiece | Console that includes the power sources, electrical components and user interface (touchscreen) Handpiece |
| Energy delivered /<br>fluence | 3-5 Joule per PZT<br>(or 6-10 J/cm²) | 3-5 Joule per PZT<br>(or 6-10 J/cm²) |
| Epidermal impact | Non-invasive | Non-invasive |
| Treatment area | 15 or 35 mm² | 15 or 35 mm² |
| User interface | LCD Touch Screen Graphic User<br>Interface | LCD Touch Screen Graphic User<br>Interface |
| | Subject Device | Predicate Device K212866 |
| Product | SofWave (Pure Impact Module) | truSculpt flex |
| 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 abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen. Strengthening, toning and firming of buttocks and thighs. | 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. |
| 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, 50/60Hz<br>Rechargeable Lithium Ion Polymer Battery Pack 3.7 V<br>Nominal Voltage: 3.7V<br>Nominal Capacity: 600mA | 100-240AC, 50/60Hz, 75VA |
| Patient Leakage<br>Current - Normal<br>Condition | Normal condition = less than 100 $\mu$ A | Normal condition = less than 100 $\mu$ A |
| Components | Console, 8 stimulation modules (up to 4 units working in parallel),<br>Maximum of 16 electrode pads per treatment | Main unit,<br>8 Stainless steel reusable electrodes pairs (16 electrodes)<br>4 electrode lead wires<br>1 AC Power Cord<br>4 Hydrogel pads<br>2 reusable silicone belts (cummerbunds) |
| Display | 15" LCD | 12" LCD |
| Number of Output<br>Channels | Maximum of 4 channels per treatment | Maximum of 4 channels per treatment |
| Method of Channel<br>Isolation | Separate units for pulse generation (wireless units). Line power is NA | Transformer |
| Regulated Current or<br>Regulated Voltage | Regulated current (all channels) | Tran conductance |
| Software/Firmware/<br>Microprocessors<br>Controls? | Yes | Yes |
| Automatic Overload<br>Trip? | Yes | Yes |
| Automatic No-Load<br>Trip | Yes | No |
| Automatic Shut off? | Yes | Yes |
| Patient Override<br>Control? | Yes | Yes |
| Indicator Display:<br>On/Off Status? | Yes | Yes |
| Low Battery? | Yes | N/A |
| Voltage/Current Level? | Yes (Energy level) | Yes |
| Timer Range (minutes) | Up to 60 minutes | 45 Minutes - For Classic mode<br>15 Minutes - for Flex+ mode |
| Compliance with<br>Voluntary 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 21<br>CFR 898 | Yes, the electrode cable can never be plugged in the AC socket, not even accidentally | Yes, the electrode cable can never be plugged in the AC socket, not even accidentally |
| Housing Material and<br>construction | PCABS510 for console covers & end point shells | ABS Plastic Body |
| Operating Temperature | Temperature: 5°C to +30°C Relative Humidity: 30% to 70 % | Temperature: +15°C to +35°C Relative Humidity: 30 % to 75 % (noncondensing) Barometric pressure: 700 hPa to 1060 hPa |
| Transport and storage<br>environment | Temperature: +5°C to +30°C Relative Humidity: 30% to 70% (noncondensing) | Temperature: +5°C to +45°C Relative Humidity: 10% to 85% (noncondensing) |

{7}------------------------------------------------

{8}------------------------------------------------

Notably, the subject Pure Impact Module has similar output waveform specifications as both the truSculpt flex predicate device and the Compex Wireless reference device. Differences in the maximum output voltage and maximum output current are minor and not clinically relevant. For all other parameters, the subject device's range is within that for the predicate and reference devices, thus not impacting substantial equivalence.

{9}------------------------------------------------

| | SofWave Pure Impact Module | | | truSculpt flex<br>Predicate Device (K212866) | | | Compex<br>Wireless<br>Reference<br>Device<br>(K143551) |
|----------------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|---------------------------------------------------------|
| | Basic | Focused | Enhanced | Tone | Prep | Sculpt | |
| Waveform | Symmetrical<br>Biphasic | Symmetrical<br>Biphasic | Symmetrical<br>Biphasic | Symmetrical<br>Biphasic | Symmetrical<br>Biphasic | Symmetrical<br>Biphasic | Symmetrical<br>Biphasic |
| Shape | Square wave | Square wave | Square wave | Square wave | Square wave | Modulated<br>Sine Wave | Rectangular |
| Maximum<br>Output<br>Voltage | 51 Vpp @<br>500 Ω (±<br>10%) | 51 Vpp @<br>500 Ω (±<br>10%) | 51 Vpp @<br>500 Ω (±<br>10%) | 70 Vpp @<br>500 Ω (±<br>10%) | 100 Vpp @<br>500 Ω (±<br>10%) | 100 Vpp @<br>500 Ω (±<br>10%) | 60 Vpp @ 500<br>Ω (± 10%) |
| | 204 Vpp @ 2<br>kΩ (± 10%) | 204 Vpp @ 2<br>kΩ (± 10%) | 204 Vpp @ 2<br>kΩ (± 10%) | 125 Vpp @ 2<br>kΩ (± 10%) | 125 Vpp @ 2<br>kΩ (± 10%) | 125 Vpp @ 2<br>kΩ (± 10%) | 180 Vpp @ 2<br>kΩ (± 10%) |
| | 228 Vpp @<br>10 kΩ (±<br>10%) | 228 Vpp @<br>10 kΩ (±<br>10%) | 228 Vpp @<br>10 kΩ (±<br>10%) | 150 Vpp @<br>10KW (±<br>10%) | 133 Vpp @<br>10 kΩ (±<br>10%) | 135 Vpp @<br>10 kΩ (±<br>10%) | 180 Vpp @ 10<br>kΩ (± 10%) |
| Maximum<br>Output<br>Current | 102 mA pp @<br>500 Ω (±<br>10%) | 102 mA pp @<br>500 Ω (±<br>10%) | 102 mA pp @<br>500 Ω (±<br>10%) | 140 mA pp @<br>500 Ω | 200 mA pp @<br>500 Ω | 200 mA pp @<br>500 Ω | 120 mA pp @<br>500 Ω |
| | 102 mA pp @<br>2 kΩ (± 10%) | 102 mA pp @<br>2 kΩ (± 10%) | 102 mA pp @<br>2 kΩ (± 10%) | 62.5 mA pp<br>@ 2 kΩ | 62.5 mA pp<br>@ 2 kΩ | 62.5 mA pp<br>@ 2 kΩ | 90 mA pp @ 2<br>kΩ |
| | 22 mA pp@<br>10 kΩ (±<br>10%) | 22 mA pp@<br>10 kΩ (±<br>10%) | 22 mA pp@<br>10 kΩ (±<br>10%) | 15 mA pp @<br>10 kΩ | 13 mA pp @<br>10 kΩ | 13.5 mA pp<br>@ 10 kΩ | 18 mA pp @<br>10 kΩ |
| Pulse Width | 250 to 350 µS<br>(± 10%)<br>@500Ω | 150 to 350 µS<br>(± 10%)<br>@500Ω | 150 to 350 µS<br>(± 10%)<br>@500Ω | 350 µS (±<br>10%) @500Ω | 125 µS (±<br>10%) @500Ω | 125 µS (±<br>10%) @500Ω | 300 to 400 µs |
| | SofWave Pure Impact Module | | | truSculpt flex | | | Compex |
| | | | | Predicate Device (K212866) | | | Wireless |
| | Basic | Focused | Enhanced | Tone | Prep | Sculpt | Reference<br>Device<br>(K143551) |
| Frequency | 1-100Hz @<br>500Ω | 1-100Hz @<br>500Ω | 1-100Hz @<br>500Ω | 99 Hz (±<br>10%) @ 500<br>Ω | Channel1:<br>4000 Hz (±<br>10%) @500<br>Ω<br>Channel 2:<br>4001 - 4100<br>Hz (± 10%)<br>@500 Ω<br>Resultant: 1 -<br>100 Hz | 4000 Hz (±<br>10%) @ 500<br>Ω<br>Resultant: 1 -<br>100 Hz | 1 to 120 Hz |
| For<br>multiphasic<br>Waveform<br>Symmetrical<br>Phases? | Yes,<br>Symmetrical<br>Biphasic | Yes,<br>Symmetrical<br>Biphasic | Yes,<br>Symmetrical<br>Biphasic | Yes,<br>Symmetrical<br>Biphasic | Yes | Yes,<br>Symmetrical<br>Biphasic | Symmetrical |
| Phase<br>duration | 250 to 350 μS<br>(± 10%)<br>@500Ω | 150 to 350 μS<br>(± 10%)<br>@500Ω | 150 to 350 μS<br>(± 10%)<br>@500Ω | 350 μS (±<br>10%) | 125 μS (±<br>10%) | 125 μS (±<br>10%) | 300 - 400 μs |
| Net charge | 0 uC @500Ω<br>(Being<br>Biphasic in<br>nature the net<br>charge would<br>be Zero) | 0 uC @500Ω<br>(Being<br>Biphasic in<br>nature the net<br>charge would<br>be Zero) | 0 uC @500Ω<br>(Being<br>Biphasic in<br>nature the net<br>charge would<br>be Zero) | 0 μC @500 Ω<br>(Being<br>Biphasic in<br>nature the net<br>charge would<br>be Zero) | 0 μC @500 Ω<br>(Being<br>Biphasic in<br>nature the net<br>charge would<br>be Zero) | 0 μC @500 Ω<br>(Being<br>Biphasic in<br>nature the net<br>charge would<br>be Zero) | 0 μC @ 500Ω<br>Excitation<br>pulse fully<br>compensated |
| Maximum<br>Phase Charge | 17.85 μC @<br>500Ω | 17.85 μC @<br>500Ω | 17.85 μC @<br>500Ω | 24.5 μC @<br>500 Ω Load | 12.5 μC @<br>500 Ω Load | 12.5 μC @<br>500 Ω Load | 48 μC @<br>500Ω |
| | SofWave Pure Impact Module | | | truSculpt flex<br>Predicate Device (K212866) | | | Compex<br>Wireless<br>Reference<br>Device<br>(K143551) |
| | Basic | Focused | Enhanced | Tone | Prep | Sculpt | |
| Maximum<br>Current<br>density | 2.04 mA/cm²<br>@ 500Ω | 2.04 mA/cm²<br>@ 500Ω | 2.04 mA/cm²<br>@ 500Ω | 2.02 mA/cm² | 2.88 mA/cm² | 2.88 mA/cm² | 1.49 mA/cm²<br>@ 500Ω |
| | *measured<br>with 50 x<br>50mm<br>rectangular<br>electrodes | *measured<br>with 50 x<br>50mm<br>rectangular<br>electrodes | *measured<br>with 50 x<br>50mm<br>rectangular<br>electrodes | *measured<br>with 59 x<br>59mm<br>rectangular<br>electrodes | *measured<br>with 59 x<br>59mm<br>rectangular<br>electrodes | *measured<br>with 59 x<br>59mm<br>rectangular<br>electrodes | *size of<br>electrodes not<br>publicly<br>available |
| Maximum<br>Power<br>Density | 0.052<br>Watt/cm² @<br>500Ω Load | 0.052<br>Watt/cm² @<br>500Ω Load | 0.052<br>Watt/cm² @<br>500Ω Load | 0.070<br>Watt/cm² | 0.144<br>Watt/cm² | 0.144<br>Watt/cm² | 27.6 mW/cm²<br>@500Ω |
| | *measured<br>with 50 x<br>50mm<br>rectangular<br>electrodes | *measured<br>with 50 x<br>50mm<br>rectangular<br>electrodes | *measured<br>with 50 x<br>50mm<br>rectangular<br>electrodes | *measured<br>with 59 x<br>59mm<br>rectangular<br>electrodes | *measured<br>with 59 x<br>59mm<br>rectangular<br>electrodes | *measured<br>with 59 x<br>59mm<br>rectangular<br>electrodes | *size of<br>electrodes not<br>publicly<br>available |
| ON Time | 6 seconds | 6 seconds | 6 seconds | NA | NA | NA | NA |
| OFF Time | 4 seconds | 4 seconds | 4 seconds | NA | NA | NA | NA |

# Comparison of Waveform Specifications

{10}------------------------------------------------

{11}------------------------------------------------

{12}------------------------------------------------

# Performance Data

The following nonclinical performance testing has been conducted to support the substantial equivalence of the SoftWave System to its predicate device. In all instances, the SoftWave System functioned as intended.

- Biocompatibility of the patient-contacting components of the device was established in ● accordance with ISO 10993-1.
- . 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, IEC 60601-2-62, and IEC 62133.
- Functional bench testing was conducted to verify that the device performance meets . its specifications.
- . Usability validation study was conducted to show that the users can safety use the device according to the instructions for use.

## Conclusion

SofWave has the same qeneral intended use and indications, similar technological characteristics, and principles of operation as the predicate devices. The minor technological differences between the subject and the predicate devices 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 predicates.