(79 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on ultrasound and electrical muscle stimulation technology without mentioning any AI/ML components.
No
The device is indicated for aesthetic treatments (improving facial lines, lifting tissues, improving cellulite appearance) rather than treating a disease or medical condition.
No
The SofWave System is described as an aesthetic treatment system for improving facial lines and wrinkles, lifting lax tissue, and improving cellulite appearance. It uses ultrasound and Electrical Muscle Stimulation (EMS) for therapeutic and aesthetic purposes, not for diagnosing medical conditions.
No
The device description clearly outlines hardware components including a console, applicator with ultrasonic transducers, and an Electrical Muscle Stimulation (EMS) module. It is an ultrasound system with physical components that deliver energy to the patient.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for non-invasive dermatological aesthetic treatments (improving facial lines and wrinkles, lifting tissue, improving cellulite, strengthening muscles). This is a therapeutic and aesthetic purpose, not for diagnosing a condition based on in vitro examination of specimens.
- Device Description: The device uses ultrasound and electrical muscle stimulation to achieve its effects. It does not involve the analysis of biological samples (blood, urine, tissue, etc.) which is a core characteristic of IVDs.
- Lack of IVD Characteristics: There is no mention of analyzing specimens, detecting biomarkers, or providing diagnostic information.
Therefore, the SofMave System, as described, falls under the category of a therapeutic or aesthetic medical device, not an In Vitro Diagnostic device.
N/A
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 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.
Product codes (comma separated list FDA assigned to the subject device)
OHV, NGX
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
facial, eyebrow, submental (beneath the chin), neck, abdomen, buttocks, thighs, legs
Indicated Patient Age Range
subjects aged 22 and older.
It is to be used by adults only.
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 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, 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The blinded reviewers correctly identified the post treatment images for 92% of the subjects.
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.
0
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"
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 (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
2
Enclosure
Office of Product Evaluation and Quality Center for Devices and Radiological Health
3
Indications for Use
Submission Number (if known)
Device Name
SofWave System
Indications for Use (Describe)
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.
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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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 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
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 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.
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.
6
| | Sofwave Medical's SofWave
System | Sofwave Medical's SofWave
System (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 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 SofWave System is
also intended for short-term
improvement in the appearance of
cellulite. |
| Device Technology | High intensity, non-focused
ultrasound | High intensity, non-focused
ultrasound |
| System components | Console that includes the
power sources, electrical
components and user
interface (touchscreen)Handpiece (Lift, Precise,
Smooth) | Console that includes the
power sources, electrical
components and user
interface (touchscreen)Handpiece (Lift, Precise) |
| Energy Type | High Intensity non-focused
Ultrasound | High Intensity non-focused
Ultrasound |
| Energy Delivered Per
Channel | 3-5 Joule per PZT (Lift and
Precise applicators)
2.6-7 Joule per PZT (Smooth
applicator) | 3-5 Joule per PZT (Lift and
Precise applicators) |
| Epidermal Impact | Non-invasive | Non-invasive |
| Treatment Area Width | Precise applicator: 15 mm2
Lift applicator: 35 mm2
Smooth applicator: 70 mm2 | Precise applicator: 15 mm2
Lift applicator: 35 mm2 |
7
| | Sofwave Medical's SofWave
System | Sofwave Medical's SofWave
System (K232455) |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject Device | (Predicate Device) |
| | | |
| User Interface | LCD Touch Screen Graphic User
Interface | LCD Touch Screen Graphic User
Interface |
| 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 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
Rechargeable Lithium Ion
Polymer Battery Pack 3.7 V
Nominal Voltage: 3.7V
Nominal Capacity: 600mA | Console Power source: 100-
240AC, 50/60Hz
Rechargeable Lithium Ion
Polymer Battery Pack 3.7 V
Nominal Voltage: 3.7V
Nominal Capacity: 600mA |
| Patient Leakage
Current - Normal
Condition | Normal condition = less than
100µA | Normal condition = less than
100µA |
| Components | Console, 8 stimulation modules
(up to 4 units working in parallel),
Maximum of 16 electrode pads
per treatment | Console, 8 stimulation modules
(up to 4 units working in parallel),
Maximum of 16 electrode pads
per treatment |
| Display | 15" LCD | 15" LCD |
| Number of Output
Channels | Maximum of 4 channels per
treatment | Maximum of 4 channels per
treatment |
| | Sofwave Medical's SofWave
System
Subject Device | Sofwave Medical's SofWave
System (K232455)
(Predicate Device) |
| Method of Channel
Isolation | Separate units for pulse
generation (wireless units). Line
power is NA | Separate units for pulse
generation (wireless units). Line
power is NA |
| Regulated Current or
Regulated Voltage | Regulated current (all channels) | Regulated current (all channels) |
| Software/Firmware/
Microprocessors
Controls? | Yes | Yes |
| Automatic Overload
Trip? | Yes | Yes |
| Automatic No-Load
Trip | Yes | Yes |
| Automatic Shut off? | Yes | Yes |
| Patient Override
Control? | 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 with
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
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
construction | PCABS510 for console covers &
end point shells | PCABS510 for console covers &
end point shells |
| Operating Temperature | Temperature: 5°C to +30°C
Relative Humidity: 30% to 70 % | Temperature: 5°C to +30°C
Relative Humidity: 30% to 70 % |
| Transport and storage
environment | Temperature: +5°C to +30°C
Relative Humidity: 30% to 70%
(noncondensing) | Temperature: +5°C to +30°C
Relative Humidity: 30% to 70%
(noncondensing) |
8
9
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.