(143 days)
Not Found
No
The document describes a radiofrequency (RF) energy delivery system with various applicators and a console. There is no mention of AI, ML, image processing, or any data-driven algorithms for diagnosis, treatment planning, or control. The performance studies focus on RF output, temperature, and tissue effects, not on the performance of any AI/ML component.
Yes
The device is described as providing relief for minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, treatment of mild to moderate facial wrinkles and rhytids, temporary reduction in the appearance of cellulite, and dermatological procedures requiring ablation and resurfacing of the skin. These are all therapeutic applications.
No
The device description and intended use primarily detail therapeutic applications (e.g., pain relief, wrinkle treatment, electrocoagulation, hemostasis) using RF energy. There is no mention of the device being used to identify or analyze a medical condition or disease.
No
The device description explicitly states it consists of a platform console, power supply, applicator connectors, RF generator, RF measuring circuit, controller, footswitch, user interface, and applicators with handles and electrodes. These are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The InMode RF Pro System uses radiofrequency energy applied directly to the body for therapeutic and aesthetic purposes (muscle pain relief, wrinkle treatment, cellulite reduction, skin ablation, electrocoagulation, hemostasis). It does not analyze samples taken from the body.
- Intended Use: The stated intended uses are all related to direct treatment or modification of the body's tissues, not the analysis of biological samples.
Therefore, the InMode RF Pro System falls under the category of therapeutic or aesthetic medical devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The InMode RF Pro System with the Non-invasive Applicators employs RF energy for various applications:
• i-Forma (Plus), Plus (Plus Plus) and Plus90 for relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation.
• WMface is intended for use in dermatologic procedures for non-invasive treatment of mild to moderate facial wrinkles and rhytids.
• BodyFX™ (WMBody)/MiniFX™ for Relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation and temporary reduction in the appearance of cellulite.
The InMode RF Pro System with the Fractional Applicators employs RF energy for various applications:
• Fractora Applicator with 60 pins tip is designed for use in dermatological procedures requiring ablation and resurfacing of the skin.
• Fractora Applicator with 24 pins tip is intended for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.
At higher energy levels greater than 62m.J/pin, use of the applicator is limited to skin types I-IV
• Morpheus8™ for dermatological and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62m.//pin, use of the applicator is limited to skin types I-IV
Product codes
GEI, PBX, ISA, NUV
Device Description
The InMode RF Pro System supports multiple radiofrequency (RF) applications and accessories. The InMode RF Pro System is compatible with the Fractional RF Applicators and the Non-Invasive RF Applicators, and employs RF energy for various applications.
The InMode RF Pro System consists of platform console with an AC/DC power supply unit, two applicator connectors, RF generator, RF measuring circuit, controller, footswitch and user interface including a touch screen. The RF Applicator is connected to the console via a cable and a footswitch activates the energy delivery to the applicator. The applicators are comprised of a handle and electrodes, and some of them are used with a single-use tip.
The below list comprises the set of applicators to be registered under the subject device:
- Non-Invasive RF Applicators:
- i-Forma
- Forma (Plus)
- Plus (Plus Plus)
- Plus90
- WMface
- BodyFX™ (WMBody)
- MiniFXTM
- Fractional RF Applicators:
- Fractora
- 24 pins tip (FRF)
- 60 pins tip
- Morpheus8™M
- 12 pins tip (Prime Tip)
- 24 pins tip (Fractora 3D)
- 40 pins tip (Body Tip)
- T tip
- Fractora
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body/facial parts requiring treatment as specified in the indication for use
Indicated Patient Age Range
Adults requiring treatment as specified in the indication for use
Intended User / Care Setting
Hospital or Clinic setting
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)
Non-Clinical (Bench) Performance Data:
The following performance data was provided in support of the substantial equivalence determination:
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the InMode RF Pro system. The system complies with the IEC 60601-1, IEC 60601-2-2 standards for safety and the IEC 60601-1-2 standard for EMC.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.
Additional Bench Testing
Bench performance tests were conducted to evaluate the performance specifications and thermal profiling of the new applicator - the i-Forma Applicator in comparison to the Forma Applicator (predicate device).
-
- Accuracy testing of the RF output parameters, temperature sensor accuracy and temperature build-up in ex-vivo model.
-
- Ex-vivo tissue study to evaluate the safety and temperature tissue penetration/depth profile
-
- Comparative test on human volunteers to evaluate the thermal effect of the InMode Pro System with the i-Forma Applicator in comparison to the predicate device
The results of the performance tests demonstrated that the InMode Pro System with the i-Forma Applicator operates in compliance with the system requirements, emitting RF energy of up to 12W, while elevating the tissue temperature up to 42ºC. Moreover, the side-by-side bench test results showed that the InMode Pro System with the i-Forma Applicator is as safe and effective as the predicate device for the same intended use.
In all, the results of the performance tests demonstrated substantial equivalence of the InMode Pro System with the i-Forma Applicator compared to the predicate device, the InMode RF Multi System with the Forma Applicator.
- Comparative test on human volunteers to evaluate the thermal effect of the InMode Pro System with the i-Forma Applicator in comparison to the predicate device
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The word "FDA" is in a larger, bolder font than the rest of the text. The overall design is clean and professional, reflecting the FDA's role in regulating food and drugs in the United States.
July 12, 2021
InMode MD Ltd. % Amit Goren Regulatory Consultant A. Stein -Regulatory Affairs Consulting Ltd. 18 Hata'as Str., Suite 21 Kfar Saba, 4442518 Israel
Re: K210492
Trade/Device Name: InMode RF Pro System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI, PBX, ISA, NUV Dated: February 9, 2021 Received: June 10, 2021
Dear Amit Goren:
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/cfpm/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.
1
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 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 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,
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
2
Indications for Use
510(k) Number (if known) K210492
Device Name InMode RF Pro System
Indications for Use (Describe)
The InMode RF Pro System with the Non-invasive Applicators employs RF energy for various applications:
• i-Forma (Plus), Plus (Plus Plus) and Plus90 for relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation.
· WMface is intended for use in dermatologic procedures for non-invasive treatment of mild to moderate facial wrinkles and rhytids.
· BodyFX™ (WMBody)/MiniFX™ for Relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation and temporary reduction in the appearance of cellulite.
The InMode RF Pro System with the Fractional Applicators employs RF energy for various applications:
· Fractora Applicator with 60 pins tip is designed for use in dermatological procedures requiring ablation and resurfacing of the skin.
· Fractora Applicator with 24 pins tip is intended for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.
At higher energy levels greater than 62m.J/pin, use of the applicator is limited to skin types I-IV
· Morpheus8™ for dermatological and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62m.//pin, use of the applicator is limited to skin types I-IV
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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3
510(K) SUMMARY INMODE RF PRO SYSTEM
510(k) Number K210492
Applicant Name:
Company Name: Address:
InMode Ltd. Tabor Building, Shaar Yokneam Yokneam 20692 Israel Tel: +972-4-9097470 Fax: +972-4-9097471 E-mail: amit@asteinrac.com
Contact Person:
| Official Correspondent: Amit Goren | |
|---|---|
| Company Name: | A. Stein - Regulatory Affairs Consulting Ltd |
| Address: | 18 Hata'as Str., Suite 102 |
| Kfar Saba 4442518 | |
| Israel | |
| Tel: +972-9-7670002 | |
| Fax: +972-9-7668534 | |
| E-mail: amit@asteinrac.com | |
| Date Prepared: | July 11, 2021 |
| Trade Name: | InMode RF Pro System |
Classification Regulation:
| Classification Name | Regulation No. | Product Code |
|---|---|---|
| Electrosurgical cutting and | ||
| coagulation device and accessories. | 878.4400 | GEI, PBX |
| Therapeutic massager. | 890.5660 | ISA |
| Laser surgical instrument for use in | ||
| general and plastic surgery and in | ||
| dermatology. | 878.4810 | NUV |
Classification: Class II Medical Device
4
Predicate Device: The InMode RF Pro System is substantially equivalent to the previously cleared predicate devices;
| Manufacturer | Device | 510(k) No. |
|---|---|---|
| InMode Ltd. | InMode RF Multi System | K201150 |
Device Description:
The InMode RF Pro System supports multiple radiofrequency (RF) applications and accessories. The InMode RF Pro System is compatible with the Fractional RF Applicators and the Non-Invasive RF Applicators, and employs RF energy for various applications.
The InMode RF Pro System consists of platform console with an AC/DC power supply unit, two applicator connectors, RF generator, RF measuring circuit, controller, footswitch and user interface including a touch screen. The RF Applicator is connected to the console via a cable and a footswitch activates the energy delivery to the applicator. The applicators are comprised of a handle and electrodes, and some of them are used with a single-use tip.
The below list comprises the set of applicators to be registered under the subject device:
- Non-Invasive RF Applicators: .
- i-Forma O
- Forma (Plus) O
- Plus (Plus Plus) O
- Plus90 O
- WMface o
- BodyFX™ (WMBody) O
- MiniFXTM O
- Fractional RF Applicators: ●
- O Fractora
- 24 pins tip (FRF) -
- -60 pins tip
- Morpheus8™M O
- 12 pins tip (Prime Tip) -
- 24 pins tip (Fractora 3D) -
- 40 pins tip (Body Tip) -
- T tip -
- O Fractora
5
| RF Max Output Power | 65 Watt |
|---|---|
| RF Output Frequency | 1[MHz] ± 2% |
| Dimensions | 36.5cm W x 39.3cm D x 111cm H |
| [14.4" W x 15.5" D x 43.7" H] | |
| Console Weight | 20.0Kg [44.0lb] |
| Main Line Frequency (nominal) | 50-60 Hz |
| Input Voltage (nominal) | 100-240 VAC |
Following are the InMode RF Multi-System device specifications:
Intended Use/Indication for Use:
The InMode RF Pro System with the Non-invasive RF Applicators employs RF energy for various applications:
- · i-Forma, Forma (Plus), Plus (Plus Plus) and Plus90 for relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation.
- WMface is intended for use in dermatologic procedures for non-invasive treatment of mild to moderate facial wrinkles and rhytids.
- BodyFX™ (WMBody)/MiniFXTM for relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation and temporary reduction in the appearance of cellulite.
The InMode RF Pro System with the Fractional Applicators employs RF energy for various applications:
- · Fractora Applicator with 60 pins tip is designed for use in dermatological procedures requiring ablation and resurfacing of the skin.
- · Fractora Applicator with 24 pins tip is intended for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62m.J/pin, use of the applicator is limited to skin types I-IV
- Morpheus8™ for dermatological and general surgical procedures for electrocoagulation and hemostasis.
At higher energy levels greater than 62mJ/pin, use of the applicator is limited to skin types I-IV
6
Performance Standards:
The InMode RF Pro System complies with the following recognized consensus standards:
- · [Rec. Number 19-4] ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- · [Rec. Number 5-89] IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- · [Rec. Number 19-8] IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- · [Rec. Number 6-389] IEC 60601-2-2 Edition 6.0 2017-03 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories ●
The test report documents conclude that the InMode RF Pro System complies with the requirements of all the above-mentioned standards. The test reports for the InMode RF Pro System are provided in section 17 of this 510(k) submission.
Non-Clinical (Bench) Performance Data:
The following performance data was provided in support of the substantial equivalence determination:
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the InMode RF Pro system. The system complies with the IEC 60601-1, IEC 60601-2-2 standards for safety and the IEC 60601-1-2 standard for EMC.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
7
The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.
Additional Bench Testing
Bench performance tests were conducted to evaluate the performance specifications and thermal profiling of the new applicator - the i-Forma Applicator in comparison to the Forma Applicator (predicate device).
-
- Accuracy testing of the RF output parameters, temperature sensor accuracy and temperature build-up in ex-vivo model.
-
- Ex-vivo tissue study to evaluate the safety and temperature tissue penetration/depth profile
-
- Comparative test on human volunteers to evaluate the thermal effect of the InMode Pro System with the i-Forma Applicator in comparison to the predicate device
The results of the performance tests demonstrated that the InMode Pro System with the i-Forma Applicator operates in compliance with the system requirements, emitting RF energy of up to 12W, while elevating the tissue temperature up to 42ºC. Moreover, the side-by-side bench test results showed that the InMode Pro System with the i-Forma Applicator is as safe and effective as the predicate device for the same intended use.
In all, the results of the performance tests demonstrated substantial equivalence of the InMode Pro System with the i-Forma Applicator compared to the predicate device, the InMode RF Multi System with the Forma Applicator.
Animal Performance Data / Histology Data:
Non-Applicable
Clinical Performance Data:
Non-Applicable
Substantial Equivalence:
The following tables provide a comparison information for the InMode RF Pro system and its predicate device, the InMode RF Multi System:
| | Subject Device
InMode RF Pro System | Predicate Device
InMode RF Multi System
K201150 | |
|------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|--|
| General | | | |
| Product Code | GEI | GEI | |
| Class | Class II | Class II | |
| Manufacturer | InMode Ltd. | InMode Ltd. | |
| | Subject Device
InMode RF Pro System | Predicate Device
InMode RF Multi System
K201150 | |
| RF platform | InMode RF Pro System | InMode RF Multi System | |
| Prescription or OTC | Prescription use only | Idem | |
| Target Population | Adults requiring treatment as
specified in the indication for use | Idem | |
| Anatomical sites | Body/facial parts requiring
treatment as specified in the
indication for use | Idem | |
| Environment Used | Hospital or Clinic setting | Idem | |
| Device description /
Design | The InMode RF Pro System is a
line power, electro thermal, radio
frequency system with integral
temperature and impedance
feedback. The system is capable of
delivering up to 65 watts of power. | Idem | |
| Device components | The InMode RF Pro System
consists of the same following
components as the InMode RF
Multi System, with additional
applicators as described in next
table:
• Electrosurgical Unit which
includes the power supply, RF
generator, controller and LCD
touch screen control and display
panel
• RF measuring circuit
• AC/DC power supply
• Designated applicators
• 2 Applicator connectors
• Footswitch | Idem | |
| Input Power | | | |
| Main Line Frequency
(nominal)
Input Voltage (nominal)
Input Current (rms) | 60 - 50Hz
100-240VAC
2A | idem | |
| Dimensions | | | |
| System | 36.5cm W x 39.3cm D x 111cm H
[14.4" W x 15.5" D x 43.7" H] | 46cm W x 46cm D x 100cm H
[18.2" W x 18.2" D x 40" H] | |
| | Subject Device
InMode RF Pro System | Predicate Device
InMode RF Multi System
K201150 | |
| Weight | | | |
| System | 20.0Kg [44.0lb] | 32.0Kg [70.5lb] | |
| RF Output Parameters | | | |
| Maximum Output Power | 65[W] | idem | |
| Frequency | 1MHz | idem | |
| Crest Factor (Rated
Load) | $1.4\pm 2%$ | idem | |
| Safety & adherence to consensus standards | | | |
| Standards Met | System adheres to:
• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-2-2 | idem | |
| Biocompatibility | Materials are biocompatible. | idem | |
| Compatibility with
Environment and Other
Devices | InMode RF Pro System is
compliant with the IEC 60601-1-2
(EMC Safety) standard | idem | |
| Electrical Safety | Power Requirements:
100-240 VAC 50-60 Hz
The InMode RF Pro System is
compliant with the IEC 60601-1
standard. | idem | |
| Mechanical Safety | The InMode RF Pro System is
compliant with the IEC 60601-1
standard. | idem | |
| Chemical Safety | Not Applicable | idem | |
| Thermal Safety | The InMode RF Pro System is
compliant with the IEC 60601-1
standard. | idem | |
| Radiation Safety | The InMode RF Pro System is
compliant with the IEC 60601-1-2
(EMC Safety) standard | idem | |
| Technological
Characteristic | Subject Device
InMode RF Pro System | Predicate Device
InMode RF Multi System
K201150 | |
| Product Code | GEI | idem | |
| Class | Class II | | |
| Manufacturer | InMode Ltd. | Idem | |
| Device Technological Characteristics | | | |
| Energy Used | Fractional RF | idem | |
| Specifications | | | |
| Max RF Energy output | 65W | idem | |
| RF Frequency | 1 MHz | idem | |
| Max RF Energy levels | FRACTORA 60 pin: 60W
InMode FRF 24 pin: 60W
Morpheus8 12, 24, 40: 60W
Morpheus8 T: 30W | idem | |
| Tip needles penetration
depth | FRACTORA 60 pin: 0.2mm
InMode FRF 24 pin: 2.5mm
Morpheus8 12 pin: 4.0mm
Morpheus8 24, 40 pins: 7.0mm
Morpheus8 T: 0.5mm | idem | |
| General Aspects | | | |
| Biocompatibility | Materials are biocompatible. | idem | |
| Sterility | All tips are Gamma-sterilized | idem | |
| Reprocessing | Handle to be reprocessed in
accordance with user manual
instructions. Tips are for single-use | idem | |
8
9
Fractional RF Applicators
10
Non-Invasive Applicators
| Technological
Characteristic | Subject Device
InMode RF Pro System | Predicate Device
InMode RF Multi System
K201150 |
|--------------------------------------|-------------------------------------------------------------|-------------------------------------------------------|
| Product Code | GEI, PBX, ISA/NUV | idem |
| Class | Class II | idem |
| Manufacturer | InMode Ltd. | idem |
| Device Technological Characteristics | | |
| Energy Used | Bipolar RF | idem |
| Specifications | | |
| Maximal RF output
power | BodyFX (WMBody): 50 [W]
WMFace: 65 [W]
MiniFX: 25 [W] | Idem |
11
| Technological
Characteristic | Subject Device
InMode RF Pro System | Predicate Device
InMode RF Multi System
K201150 |
|---------------------------------|----------------------------------------------------------------------------------|-------------------------------------------------------|
| | Forma (Plus), Plus (Plus-Plus): 50 [W]
i-Forma: 12 [W]
Plus90: 50 [W] | NA |
| RF Frequency | 1 MHz | idem |
| General Aspects | | |
| Biocompatibility | Materials are biocompatible. | idem |
| Sterility | NA | NA |
| Reprocessing | Applicators to be reprocessed in
accordance with user manual
instructions. | idem |
The indications for use and technological characteristics of the InMode RF Pro System are substantially equivalent to the indications for use and technological characteristics of the InMode RF Multi System (predicate device, subject of K201150).
The design of and components included in the InMode RF Pro System, including the main system platform, with power supply, RF generator, controller and display panel are similar to the design and components found in the predicate device except for slight design modifications to support the utilization of the i-Forma applicator in addition to all previously FDA cleared device applicators, mainly in software design. The subject device applicators possess identical technological principals to the predicate device applicators. Both the subject and predicate device present identical performance specifications (for the specified indications for use) and identical monitoring features (where applicable) in order to maintain the desired performance specifications. The safety features and compliance with safety standards in the InMode RF Pro System are similar to the safety features and compliance with safety standards found in the predicate device. Patient contacting materials are also identical. Any minor differences in the technological characteristics do not raise new safety or effectiveness concerns. Furthermore, the subject device underwent performance testing including software validation testing, electrical and mechanical safety testing according to IEC 60601-1, electromagnetic compatibility testing according to IEC 60601-1-2 and high frequency of surgical equipment testing according to IEC 60601-2-2. User interface was slightly changed in order to support all applicators, and labelling was updated to allow appropriate use.
Conclusions:
Based upon the intended use, technological characteristics and performance testing comparison data, the K210492 subject device has been determined to be substantially equivalent to and as safe and effective as the K201150 predicate device.