InMode RF Multi-System

K201150 · InMode , Ltd. · GEI · Jul 22, 2020 · General, Plastic Surgery

Device Facts

• Record ID: K201150
• Device Name: InMode RF Multi-System
• Applicant: InMode , Ltd.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jul 22, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The InMode RF Multi-System with the Non-invasive Applicators employs RF energy for various applications: •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)/MimiFX™ 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 Multi-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!/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

Device Story

InMode RF Multi-System is a line-powered, electro-thermal radiofrequency (RF) platform for dermatological and surgical applications. System comprises a console with RF generator, controller, LCD touch screen, and footswitch; connects to various fractional or non-invasive applicators. Physician operates device in hospital or clinic settings. Input consists of user-selected energy parameters; device delivers RF energy (1 MHz) to tissue via applicator electrodes. Integral temperature and impedance feedback mechanisms monitor energy delivery. Output is thermal energy for coagulation, hemostasis, ablation, or muscle/circulation therapy. Clinical benefit includes wrinkle reduction, cellulite appearance improvement, and surgical hemostasis. Device consolidates multiple previously cleared InMode applicators onto a single console platform.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and high-frequency surgical equipment performance (IEC 60601-2-2), alongside software verification and validation.

Technological Characteristics

Platform: Electrosurgical RF generator (1 MHz, max 65W). Components: Console, touch screen, footswitch, RF measuring circuit. Applicators: Fractional (pin-based) and non-invasive (bipolar). Materials: Biocompatible. Sterilization: Gamma-sterilized tips (single-use). Connectivity: Standalone console. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-1-6.

Indications for Use

Indicated for adults requiring relief of minor muscle aches, pain, and spasms; temporary improvement of local blood circulation; temporary reduction in cellulite appearance; non-invasive treatment of mild to moderate facial wrinkles/rhytids; and dermatological/general surgical procedures for skin ablation, resurfacing, electrocoagulation, and hemostasis. Higher energy levels (>62mJ/pin) limited to skin types I-IV.

Regulatory Classification

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.

Predicate Devices

• InMode RF System (K182325)

Reference Devices

• InMode System MiniFX Applicator (K160329)
• InMode WMBody Device (K131362)
• InMode PLUS System (K172302)
• WMFACE Applicator (K140926)
• FRACTORA 60 pin (K102461)
• InMode System with Fractora3D/3D-90 Applicators (K180189)
• InMode FRF 24 pin Applicator (K151273)
• InMode System with the Morpheus8 12, 24, 40 & T Applicators (K192695)
• InMode System with the Morpheus8 Applicators (K200947)

Submission Summary (Full Text)

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July 22, 2020

InMode Ltd. % Amit Goren Regulatory Manager A. Stein - Regulatory Affairs Consulting Ltd. 20 Hata'as Str., Suite 102 Kfar Saba, 4442520 Israel

Re: K201150

Trade/Device Name: InMode RF Multi-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: April 22, 2020 Received: April 29, 2020

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/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.

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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 ([e-mail]) or phone [phone] 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

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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

K201150

Device Name InMode RF Multi-System

#### Indications for Use (Describe)

The InMode RF Multi-System with the Non-invasive Applicators employs RF energy for various applications:

•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)/MimiFX™ 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 Multi-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!/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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# 510(K) SUMMARY INMODE RF MULTI-SYSTEM

# 510(k) Number K201150

# Applicant Name:

Company Name: Address:

InMode Ltd. Tabor Building, Shaar Yokneam Yokneam 20692 Israel Tel: [phone] Fax: [phone] E-mail: [e-mail]

## Contact Person:

| Official Correspondent: | Amit Goren |
|-------------------------|-----------------------------------------------------------|
| Company Name: | A. Stein – Regulatory Affairs Consulting Ltd. |
| Address: | 20 Hata'as Str., Suite 102<br>Kfar Saba 4442500<br>Israel |
| | Tel: [phone] |
| | Fax: [phone] |
| | E-mail: [e-mail] |
| Date Prepared: | July 21, 2020 |
| Trade Name: | InMode RF Multi-System |

# Classification Regulation:

| Classification Name | Regulation No. | Product Code |
|--------------------------------------------------------------------------------------------|----------------|--------------|
| Electrosurgical cutting and<br>coagulation device and accessories. | 878.4400 | GEI, PBX |
| Therapeutic massager. | 890.5660 | ISA |
| Laser surgical instrument for use in<br>general and plastic surgery and in<br>dermatology. | 878.4810 | NUV |

Classification: Class II Medical Device

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| Manufacturer | Device | 510(k) No. |
|----------------------|-------------------------------------------------------------|------------|
| Main Predicate | | |
| InMode Ltd. | InMode RF System | K182325 |
| Reference Predicates | | |
| InMode Ltd. | InMode System MiniFX Applicator | K160329 |
| InMode Ltd. | InMode WMBody Device | K131362 |
| InMode Ltd. | InMode PLUS System | K172302 |
| InMode Ltd. | WMFACE Applicator | K140926 |
| InMode Ltd. | FRACTORA 60 pin | K102461 |
| InMode Ltd. | InMode System with Fractora3D/3D-90 Applicators | K180189 |
| InMode Ltd. | InMode FRF 24 pin Applicator | K151273 |
| InMode Ltd. | InMode System with the Morpheus8 12, 24, 40 & T Applicators | K192695 |
| InMode Ltd. | InMode System with the Morpheus8 Applicators | K200947 |

Predicate Device: The InMode RF Multi-System is substantially equivalent to the previously cleared predicate devices;

# Device Description:

The InMode RF Multi-System supports multiple radiofrequency (RF) applications and accessories. The InMode RF Multi-System is compatible with the Fractional RF Applicators and the Non-Invasive RF Applicators, and employs RF energy for various applications.

The InMode RF Multi-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.

This 510(k)-file submission includes all the FDA-Cleared applicators under one submission with the RF-supporting console, as cleared in K182325, compatible with all applicators.

The below list comprises the set of applicators to be registered under the subject device:

- . Non-Invasive RF Applicators:
- Forma (Plus) O
- Plus (Plus Plus) O
- Plus90 O
- WMface O
- BodyFXTM (WMBody) O
- MiniFX™ O

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- Fractora O
- 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

Following are the InMode RF Multi-System device specifications:

| RF Max Output Power | 65 Watt |
|-------------------------------|----------------------------------------------------------|
| RF Output Frequency | 1[MHz] ± 2% |
| Dimensions | 46cm W x 46cm D x 100cm H<br>[18.2" W x 18.2" D x 40" H] |
| Console Weight | 32.0Kg [70.548lb] |
| Main Line Frequency (nominal) | 50-60 Hz |
| Input Voltage (nominal) | 100-240 VAC |

#### Intended Use/Indication for Use:

The InMode RF Multi-System with the Non-invasive RF Applicators employs RF energy for various applications:

- 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 Multi-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 62mJ/pin, use of the applicator is limited to skin types I-IV
- · Morpheus8™ for dermatological and general surgical procedures for electrocoagulation and hemostasis.

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At higher energy levels greater than 62mJ/pin, use of the applicator is limited to skin types I-IV

# Performance Standards:

The InMode RF Multi-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 certificates and test reports documents conclude that the InMode RF Multi-System complies with the requirements of all the above-mentioned standards. The test certificates and reports for the InMode RF Multi System are provided in section 17 of this 510(k) submission.

# Non-Clinical (Bench) Performance Data:

The following performance data were 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 Multi-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.

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## 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.

## 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 Multisystem and its main predicate, the InMode RF System and for the subject device applicators and their compatible predicate reference devices:

| | Subject Device<br>InMode RF Multi-System<br>K201150 | Main Predicate Device<br>InMode RF System<br>K182325 |
|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General | | |
| Product Code | GEI | GEI |
| Class | Class II | Class II |
| Manufacturer | InMode Ltd. | InMode Ltd. |
| RF platform | InMode RF Multi-System | InMode RF System |
| Prescription or OTC | Prescription use only | Idem |
| Target Population | Adults requiring treatment as<br>specified in the indication for<br>use | Idem |
| Anatomical sites | Body parts requiring treatment<br>as specified in the indication<br>for use | Idem |
| Environment Used | Hospital or Clinic setting | Idem |
| Device description /<br>Design | The InMode RF Multi-System<br>is a line power, electro<br>thermal, radio frequency<br>system with integral<br>temperature and impedance<br>feedback. The system is | The InMode RF System is a<br>line power, electro thermal,<br>radio frequency system with<br>integral temperature and<br>impedance feedback. The<br>system is capable of |
| | Subject Device<br>InMode RF Multi-System<br>K201150 | Main Predicate Device<br>InMode RF System<br>K182325 |
| | capable of delivering up to 65 watts of power. | delivering up to 40 watts of power. |
| Device components | The InMode RF Multi-System consists of the same following components as the InMode RF System, with additional applicators as described in next table:<br>• Electrosurgical Unit which includes the power supply, RF generator, controller and LCD touch screen control and display panel<br>• RF measuring circuit<br>• AC/DC power supply<br>• Designated applicators<br>• 2 Applicator connectors<br>• Footswitch | The InMode RF System consists of the following components:<br>• Electrosurgical Unit which includes the power supply, RF generator, controller and LCD touch screen control and display panel<br>• RF measuring circuit<br>• AC/DC power supply<br>• Applicators<br>• Applicators connector<br>• Footswitch |
| Input Power | | |
| Main Line Frequency (nominal)<br>Input Voltage (nominal)<br>Input Current (rms) | 60 - 50Hz<br>100-240VAC<br>2A | idem |
| Dimensions | | |
| System | 46cm W x 46cm D x 100cm H<br>[18.2" W x 18.2" D x 40" H] | idem |
| Weight | | |
| System | 32.0Kg [70.51b] | idem |
| RF Output Parameters | | |
| Maximum Output Power | 65[W] | 40[W] |
| Frequency | 1MHz | idem |
| Crest Factor (Rated Load) | $1.4\pm 2%$ | idem |
| Safety & adherence to consensus standards | | |
| | Subject Device<br>InMode RF Multi-System<br>K201150 | Main Predicate Device<br>InMode RF System<br>K182325 |
| Standards Met | System adheres to:<br>• IEC 60601-1<br>• IEC 60601-1-2<br>• IEC 60601-2-2 | idem |
| Biocompatibility | Materials are biocompatible. | idem |
| Compatibility with<br>Environment and Other<br>Devices | InMode RF System is<br>compliant with the IEC 60601-<br>1-2 (EMC Safety) standard | idem |
| Electrical Safety | Power Requirements:<br>100-240 VAC 50-60 Hz<br>The InMode RF System is<br>compliant with the IEC 60601-<br>1 standard. | idem |
| Mechanical Safety | The InMode RF System is<br>compliant with the IEC 60601-<br>1 standard. | idem |
| Chemical Safety | Not Applicable | idem |
| Thermal Safety | The InMode RF System is<br>compliant with the IEC 60601-<br>1 standard. | idem |
| Radiation Safety | The InMode RF System is<br>compliant with the IEC 60601-<br>1-2 (EMC Safety) standard | idem |

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| Technological<br>Characteristic | Subject Device<br>InMode RF Multi-System<br>K201150 | Reference Predicates<br>K102461 - FRACTORA 60<br>pin Applicator<br>K151273 - InMode FRF 24<br>pin Applicator<br>K192695 & K200947-<br>Morpheus8 (Fractora 3D)<br>Applicator with the 12, 24,<br>40 & T tip heads |
|--------------------------------------|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | GEI | idem |
| Class | Class II | idem |
| Manufacturer | InMode Ltd. | Idem |
| Device Technological Characteristics | | |
| Energy Used | Fractional RF | idem |
| Specifications | | |
| Max RF Energy output | 65W | idem |

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| Technological<br>Characteristic | Subject Device<br>InMode RF Multi-System<br>K201150 | Reference Predicates<br>K102461 - FRACTORA 60<br>pin Applicator<br>K151273 - InMode FRF 24<br>pin Applicator<br>K192695 & K200947-<br>Morpheus8 (Fractora 3D)<br>Applicator with the 12, 24,<br>40 & T tip heads |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| RF Frequency | 1 MHz | idem |
| Max RF Energy levels | FRACTORA 60 pin: 60W<br>InMode FRF 24 pin: 60W<br>Morpheus8 12, 24, 40: 60W<br>Morpheus8 T: 30W | FRACTORA 60 pin: 62W<br>InMode FRF 24 pin: 62W<br>Morpheus8 12, 24 & 40: 60W<br>Morpheus8 T: 30W |
| Tip needles penetration<br>depth | FRACTORA 60 pin: 0.2mm<br>InMode FRF 24 pin: 2.5mm<br>Morpheus8 12, 24 pins:<br>4.0mm<br>Morpheus8 40 pin: 7.0mm<br>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<br>accordance with user manual<br>instructions. Tips are for<br>single-use | idem |

| Technological<br>Characteristic | Subject Device<br>InMode RF Multi-System | Reference Predicates<br>K131362- BodyFX<br>(WMBody)<br>K140926-WMFace<br>K160329- MiniFX<br>K172302- Forma (Plus),<br>Plus90 and Plus (Plus-Plus) |
|--------------------------------------|-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code<br>Class | GEI, PBX, ISA/NUV<br>Class II | idem |
| Manufacturer | InMode Ltd. | idem |
| Device Technological Characteristics | | |
| Energy Used | Bipolar RF | idem |
| Specifications | | |
| Maximal RF output<br>power | BodyFX (WMBody): 50 [W]<br>WMFace: 65 [W]<br>MiniFX: 25 [W] | idem |

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| Technological<br>Characteristic | Subject Device<br>InMode RF Multi-System | Reference Predicates<br>K131362- BodyFX<br>(WMBody)<br>K140926-WMFace<br>K160329- MiniFX<br>K172302- Forma (Plus),<br>Plus90 and Plus (Plus-Plus) |
|---------------------------------|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| | Forma (Plus), Plus (Plus-<br>Plus): 50 [W]<br>Plus90: 50 [W] | |
| RF Frequency | 1 MHz | idem |
| General Aspects | | |
| Biocompatibility | Materials are biocompatible. | idem |
| Sterility | NA | NA |
| Reprocessing | Applicators to be reprocessed<br>in accordance with user<br>manual instructions. | idem |

The indications for use and technological characteristics of the InMode RF Multi-System are substantially equivalent to the indications for use and technological characteristics of the InMode RF System (predicate device, subject of K182325) and applicators (reference devices).

The design of and components included in the InMode RF Multi-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 main predicate device except for slight design modifications to support the utilization of all of the system applicators, mainly in software design. The subject device applicators possess similar technological principals to the predicate devices' applicators. Minor changes were done for some of the applicators, still the device performance and safety are maintained due to the exact functionality and mechanism of operation. Both the subject and predicate devices present similar performance specifications (for the specified indications for use) and similar monitoring features (where applicable) in order to maintain the desired performance specifications. The safety features and compliance with safety standards in the InMode RF Multi-System are similar to the safety features and compliance with safety standards found in the predicate device. Patient contacting materials are also similar. 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 labeling was updated to allow appropriate use.

Consequently, it can be concluded that the InMode RF Multi-System is substantially equivalent to the predicate InMode RF System, cleared under 510(k) K182325 and the

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InMode RF Multi-System 510(k) file Section 5 – 510(k) Summary

reference device cleared under 510(k) K1024615, K131362, K140926, K1512735, K160329, K172302, K180189, K192695 and K200947 and therefore, may be legally marketed in the USA.

Therefore, the InMode RF Multi-System may be legally marketed in the USA.

#### Conclusions:

Based on the performance testing and comparison to predicate device and reference devices, the InMode RF Multi-System is substantially equivalent to the InMode RF System (predicate device) and Applicators (reference devices).