(58 days)
Not Found
No
The summary does not mention AI, ML, or any related technologies in the device description or performance studies. The device operates based on controlled thermal damage from ultrasonic pulses.
Yes
The device is intended to treat specific medical conditions, such as improving facial lines and wrinkles, lifting lax tissue, and improving the appearance of cellulite. These are considered therapeutic indications.
No
The device is described as a non-invasive dermatological aesthetic treatment for improving facial lines and wrinkles, lifting the eyebrow, and lifting lax submental and neck tissue, as well as for short-term improvement in the appearance of cellulite. Its purpose is to treat aesthetic conditions, not to diagnose a disease or condition.
No
The device description clearly states that the SofWave System consists of both a console and an applicator, which are hardware components. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "non-invasive dermatological aesthetic treatment" to improve facial lines, wrinkles, lift tissue, and improve the appearance of cellulite. This is a therapeutic and aesthetic purpose, not a diagnostic one.
- Device Description: The device description details an ultrasound system that generates thermal damage in the dermis for aesthetic purposes. It does not mention analyzing biological samples (blood, urine, tissue, etc.) which is a hallmark of IVD devices.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information about a disease or condition.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is entirely focused on altering tissue for aesthetic improvement.
N/A
Intended Use / Indications for Use
The Softem 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 SoftWave System is also intended for short-term improvement in the appearance of cellulite.
Product codes (comma separated list FDA assigned to the subject device)
OHV
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
High intensity therapeutic ultrasound
High Intensity non-focused Ultrasound
Anatomical Site
facial lines and wrinkles, eyebrow, lax submental (beneath the chin) and neck tissue, lateral / posterior upper thigh or buttocks
Indicated Patient Age Range
22 and older
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The company conducted a clinical study that evaluated the safety and effectiveness of 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 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 posttreatment 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The blinded reviewers correctly identified the post treatment images for 89% of the subjects.
The mean pain level was 4.6 (moderate pain).
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4590 Focused ultrasound stimulator system for aesthetic use.
(a)
Identification. A Focused Ultrasound Stimulator System for Aesthetic Use is a device using focused ultrasound to produce localized, mechanical motion within tissues and cells for the purpose of producing either localized heating for tissue coagulation or for mechanical cellular membrane disruption intended for noninvasive aesthetic use.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.
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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
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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 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-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 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-device-safety/medical-device-reportingmdr-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/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,
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
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510(k) Number (if known) K223237
Device Name
SofWave System
Indications for Use (Describe)
The Softem 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 SoftWave 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)
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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.
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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 SoftWave 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.
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| | Sofwave Medical's
SofWave System
(Subject Device) | Sofwave Medical's
SofWave System
(K211483)
(Predicate Device) | Soliton RAP for Cellulite
(K201801)
(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
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. | 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 Rapid Acoustic Pulse
Device (RAP) is indicated for
use as an accessory to the
1064 nm Q-Switched laser
for black ink tattoo removal
in Fitzpatrick Skin Type I-III
patients. The RAP device is
also intended for short-term
improvement in the
appearance of cellulite. |
| Device
Technology | High intensity, non-focused
ultrasonic pulse that can be
delivered percutaneously to
tissues to reduce fibrous
septa's tendency to deform
the skin surface | High intensity, non-focused
ultrasonic pulse that can be
delivered percutaneously to
tissues | Acoustic pulse that partially
disrupts the fibrous septa to
improve cellulite
appearance. |
| Type of Energy | High intensity therapeutic
ultrasound | High intensity therapeutic
ultrasound | Acoustic shockwave |
| 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 | Console that includes
• the power sources,
electrical components
and user interface
(touchscreen)
• Handpiece |
| Energy Type | High Intensity non-focused
Ultrasound | High Intensity non-focused
Ultrasound | Broadband/Ultrasonic |
| Treatment Depth | 1-2 mm | 1-2 mm | 1-10 mm* |
| Tissue at Focal
Point Temperature | 60°C -70°C | 60°C -70°C | N/A |
| Thermal Energy
Output per
channel |