December 16, 2022
Sofwave Medical Ltd.
℅ Janice Hogan
Partner
Hogan Lovells US LLP
1735 Market Street
Floor 23
Philadelphia, Pennsylvania 19103
Re: K223237
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
Dated: October 19, 2022
Received: October 19, 2022
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 (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
located 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.
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
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID# 04017.05.02
Silver Spring, MD 20993
www.fda.gov
K223237 - Janice Hogan Page 2
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 803) for
devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for
combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part
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-
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,
Jessica Carr -S
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120
Food and Drug Administration Expiration Date: 06/30/2023
Indications for Use See PRA Statement below
510(k) Number (if known)
K223237
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 regions for subjects aged 22 and older. The SofWave
System is also intended for short-term improvement in the appearance of cellulite.
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
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FORM FDA 3881 (8/20) Page 1 of 1 057
PSC Publishing Services (301) 443-6740 EF
K223237 page 1 of 5
510(k) SUMMARY
Sofwave Medical’s SofWave System
K223237
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: December 15, 2022
Name of Device:
SofWave System
Common or Usual Name:
Focused Ultrasound Stimulator System for Aesthetic Use
Classification Name:
21 CFR 878.4590 (Ultrasound for Tissue Heat or Mechanical Cellular Disruption), Class II,
product code OHV
Predicate Devices
Sofwave Medical’s SofWave System (K211483) (Predicate Device)
Soliton Inc.’s Rapid Acoustic Pulse (RAP) Device (K201801) (Predicate device)
Intended Use / Indications for 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 regions
for subjects aged 22 and older. The SofWave System is also intended for short-term improvement
in the appearance of cellulite.
K223237 page 2 of 5
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 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.
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 SofWave device that was cleared
in K211483, except minor hardware and software changes, which do not significantly affect clinical
functionality or performance specifications of the device, and have been verified and tested. The
treatment parameter or energy specification of the device remain identical to that cleared in
K211483. The purpose of this 510(k) notification is to expand the indications for use to include
short-term improvement in the appearance of cellulite. This additional indication for use does not
require any additional hardware or software changes to the device.
The subject SofWave device is also similar to the Soliton RAP predicate device (K201801) that is
indicated for short-term improvement in the appearance of cellulite. Both devices are comprised
of a console and a treatment applicator. Both devices deliver acoustic energy into the skin to alter
the structure of the tissue, resulting in improved appearance of cellulite. The minor differences in
the technology do not raise different questions of safety or effectiveness. For both devices, the
same types of safety and efficacy questions arise. Clinical testing further demonstrates the
performance of the SofWave device, showing that the magnitude of the clinical effects with
treatment is comparable between SofWave and the Soliton RAP device.
K223237 page 3 of 5
SofWave System Substantial Equivalence Chart
Sofwave Medical’s Sofwave Medical’s Soliton RAP for Cellulite
SofWave System SofWave System (K201801)
(K211483)
(Subject Device) (Predicate Device) (Predicate Device)
Regulatory Class II II II
CFR Regulation 21 CFR 878.4590 21 CFR 878.4590 21 CFR 878.4810
Product Code OHV OHV GEX
Intended Use The SofWave System is The SofWave System is The Rapid Acoustic Pulse
indicated for use as a non- indicated for use as a non- Device (RAP) is indicated for
invasive dermatological invasive dermatological use as an accessory to the
aesthetic treatment to aesthetic treatment to 1064 nm Q-Switched laser
improve facial lines and improve facial lines and for black ink tattoo removal
wrinkles, lift the eyebrow, wrinkles, lift the eyebrow, in Fitzpatrick Skin Type I-III
and lift lax submental and lift lax submental patients. The RAP device is
(beneath the chin) and neck (beneath the chin) and neck also intended for short-term
tissue; which can also affect tissue; which can also affect improvement in the
the appearance of lax tissue the appearance of lax tissue appearance of cellulite.
in the submental and neck in the submental and neck
regions for subjects aged regions for subjects aged
22 and older. The SofWave 22 and older.
System is also intended for
short-term improvement in
the appearance of cellulite.
Device High intensity, non-focused High intensity, non-focused Acoustic pulse that partially
Technology ultrasonic pulse that can be ultrasonic pulse that can be disrupts the fibrous septa to
delivered percutaneously to delivered percutaneously to improve cellulite
tissues to reduce fibrous tissues appearance.
septa’s tendency to deform
the skin surface
Type of Energy High intensity therapeutic High intensity therapeutic Acoustic shockwave
ultrasound ultrasound
System • Console that includes • Console that includes • Console that includes
components the power sources, the power sources, the power sources,
electrical components electrical components electrical components
and user interface and user interface and user interface
(touchscreen) (touchscreen) (touchscreen)
• Handpiece • Handpiece • Handpiece
Energy Type High Intensity non-focused High Intensity non-focused Broadband/Ultrasonic
Ultrasound Ultrasound
Treatment Depth 1-2 mm 1-2 mm 1-10 mm*
Tissue at Focal 60°C -70°C 60°C -70°C N/A
Point Temperature
Thermal Energy < 5J per channel < 5J per channel N/A
Output per
channel
Thermal Confined to focal zone; Confined to focal zone; N/A
Coagulation Point shallow (<3 mm); no shallow (<3 mm); no
thermal coagulation below thermal coagulation below
focal zone
focal zone
Epidermal Impact Non-invasive; Cooling Non-invasive; Cooling Non-invasive
required required
K223237 page 4 of 5
Sofwave Medical’s Sofwave Medical’s Soliton RAP for Cellulite
SofWave System SofWave System (K201801)
(K211483)
(Subject Device) (Predicate Device) (Predicate Device)
Transducer Energizer comprises: Energizer comprises: Cartridge is comprised of
Acoustic Core - Array of - Array of electrodes immersed in the
piezoelectric piezoelectric circulating saline
ceramic plates (7 x ceramic plates (7 x
5 mm2) 5 mm2)
- Temperature - Temperature
control unit control unit
(thermistors, (thermistors,
Thermoelectric Thermoelectric
cooler (TEC), Heat cooler (TEC), Heat
Exchanger) Exchanger)
Frequency 10 MHz – 12 MHz 10 MHz – 12 MHz N/A
Treatment Area 35mm 35mm 38mm
Width
Peak Acoustic 1.2 MPa 1.2 MPa 0.25 to 12 MPa
Pressure
User Interface LCD Touch Screen Graphic LCD Touch Screen Graphic LCD Touch Screen Graphic
User Interface User Interface User Interface
Electrical IEC 60601-1 Compliant IEC 60601-1 Compliant IEC 60601-1 Compliant
Safety/EMC IEC 60601-1-2 Compliant IEC 60601-1-2 Compliant IEC 60601-1-2 Compliant
Input Power 100-240VAC 100-240VAC 240VAC
60Hz 60Hz 60Hz
10A 10A 15A
* Based on publicly available information for Soliton
Performance Data
The following nonclinical performance testing has been conducted to support the substantial
equivalence of the SofWave 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, and IEC 60601-2-62
• Functional bench testing was conducted to verify that the modifications to the device
did not affect the device performance
To support the expansion of indications for cellulite, the company conducted a clinical study that
evaluated the safety and effectiveness of the device for the non-invasive dermatological aesthetic
improvement in cellulite appearance. A total of 69 subjects were enrolled and 68 subjects were
treated at 4 sites in the United States.
Eligible patients received 2 treatments (2-4 weeks apart) using the SofWave System on one side
(right or left) of the lateral / posterior upper thigh or buttocks. Serial clinical photographs were
K223237 page 5 of 5
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 89% of the subjects.
Throughout the study, there was only one adverse event reported, which was not related to the
device. No serious or unanticipated adverse event was reported during the study. The mean pain
level was 4.6 (moderate pain). Based on a literature review, the study results were consistent with
the predicate device.
Conclusion
SofWave has the same general intended use and similar indications, technological characteristics,
and principles of operation as the company’s previously cleared SofWave System (K211483) and
Soliton’s RAP device (K201801) (“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.
