• 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 62mJ/pin, use of the applicator is limited to skin types I-IV

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.

AI/ML Overview

The provided text describes the FDA 510(k) clearance for the InMode RF Pro System, demonstrating substantial equivalence to a predicate device (InMode RF Multi System, K201150). The study focuses on safety and performance rather than diagnostic accuracy or human reader improvement with AI. Therefore, many standard acceptance criteria for AI-powered diagnostic devices (e.g., sensitivity, specificity, F1 score, MRMC studies) are not applicable here.

Below is an adaptation of your requested table and information based on the available data, focusing on the device's substantial equivalence through performance and safety testing.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance (InMode RF Pro System)
Electrical Safety	Compliance with IEC 60601-1	Complies with IEC 60601-1:2005/(R)2012, A1:2012, C1:2009/(R)2012, and A2:2010/(R)2012 (Consolidated Text) for basic safety and essential performance.
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2	Complies with IEC 60601-1-2 Edition 4.0 2014-02 for electromagnetic disturbances.
High-Frequency Surgical Equipment Safety	Compliance with IEC 60601-2-2	Complies with IEC 60601-2-2 Edition 6.0 2017-03 for basic safety and essential performance of high-frequency surgical equipment.
Usability	Compliance with IEC 60601-1-6	Complies with IEC 60601-1-6 Edition 3.1 2013-10 for usability.
Software Verification & Validation	Compliance with FDA guidance for "major" level of concern	Software verification and validation testing conducted, documentation provided as recommended by FDA guidance ("Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"). Software considered "major" level of concern.
Performance Specifications (RF Output)	Maintain RF output parameters similar to predicate.	RF Max Output Power: 65 Watt (same as predicate)
	Maintain RF output frequency similar to predicate.	RF Output Frequency: 1 MHz ± 2% (same as predicate)
Thermal Performance (i-Forma Applicator)	Accuracy of RF output parameters.	Accuracy testing performed on RF output parameters, temperature sensor accuracy, and temperature build-up in an ex-vivo model. Results demonstrated compliance with system requirements.
	Tissue penetration/depth profile (ex-vivo).	Ex-vivo tissue study evaluated safety and temperature tissue penetration/depth profile.
	Thermal effect in human volunteers vs. predicate.	Comparative test on human volunteers evaluated the thermal effect of the InMode Pro System with the i-Forma Applicator in comparison to the predicate device. Results: i-Forma Applicator emits up to 12W, elevating tissue temperature up to 42ºC, demonstrating it is as safe and effective as the predicate for the same intended use.
Biocompatibility	Materials are biocompatible.	Materials are biocompatible (same as predicate).
Sterility (for tips)	Gamma-sterilized.	All tips are Gamma-sterilized (same as predicate).
Reprocessing	Manual instructions followed for handles/applicators.	Handles/Applicators reprocessed according to user manual instructions. Tips are single-use (same as predicate).
Substantial Equivalence to Predicate Device	Indications for use are substantially equivalent.	Indications for use are substantially equivalent to the InMode RF Multi System.
	Technological characteristics are equivalent.	Technological characteristics are similar; minor design modifications (mainly software) support i-Forma. Identical technological principles, performance specifications, and monitoring features. Safety features and compliance with standards are similar. Patient contacting materials are identical.

Study Details:

The document describes several non-clinical studies and tests performed to demonstrate the device's safety and effectiveness, primarily through comparison to a predicate device for the purpose of 510(k) clearance.

2. Sample Size Used for the Test Set and the Data Provenance

Electrical Safety & EMC Testing: Sample size not specified, but typically involves testing a representative number of units or a single unit for regulatory compliance. Data provenance is internal testing performed by the manufacturer or accredited labs based on international standards.
Software Verification & Validation: Sample size for testing not specified, but covers the entire software system. Data provenance is internal software development and testing.
Bench Testing (i-Forma Applicator):
- Ex-vivo tissue study: Sample size not specified for the ex-vivo model (e.g., number of tissue samples). Data provenance is internal lab testing.
- Comparative test on human volunteers: The document states "human volunteers," but does not specify the number of volunteers. Data provenance would be a clinical study, likely conducted by the manufacturer. This would be considered prospective data collection.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable as the studies were focused on device performance and safety (e.g., electrical, thermal, software verification) against established engineering and medical device standards, rather than diagnostic accuracy requiring expert consensus on "ground truth." The "ground truth" for these tests would be the measured physical parameters, the functionality of the software, and the physiological response (temperature elevation) in tissue/volunteers, compared against predetermined specifications and the predicate device.

4. Adjudication Method for the Test Set

Not applicable in the context of device safety and performance testing against objective standards or direct comparison to a predicate. Results are typically quantitative measurements and observations, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This device is not an AI-powered diagnostic system aimed at improving human reader performance. It is an RF energy delivery system for aesthetic and medical treatments.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This is an RF energy delivery system, not a standalone AI algorithm. The performance studies evaluate the physical device's operation, safety, and functionality.

7. The Type of Ground Truth Used

For Electrical Safety, EMC, Usability, High-Frequency Surgical Equipment Safety: Compliance with specific international consensus standards (IEC 60601-1, -1-2, -1-6, -2-2). The "ground truth" is adherence to the technical requirements and limits defined by these standards.
For Software Verification and Validation: Adherence to FDA guidance for software in medical devices and the software's specified functional requirements.
For Bench Testing (i-Forma Applicator):
- Accuracy of RF output parameters & temperature sensor accuracy: Measured values against calibration standards and design specifications.
- Temperature build-up in ex-vivo model & ex-vivo tissue study: Measured temperature and tissue penetration against expected physiological effects and comparison to the predicate device.
- Comparative test on human volunteers: Measured thermal effect (e.g., temperature elevation) against the thermal effect of the predicate device and safety thresholds.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML-driven diagnostic or analytical tool that requires a "training set" in the conventional sense. The software is likely deterministic control software, validated against specifications rather than trained on data.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no "training set."

Summary

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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.

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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 (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

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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.

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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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 andcoagulation device and accessories.	878.4400	GEI, PBX
Therapeutic massager.	890.5660	ISA
Laser surgical instrument for use ingeneral and plastic surgery and indermatology.	878.4810	NUV

Classification: Class II Medical Device

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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 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 -

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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

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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."

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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).

1. Accuracy testing of the RF output parameters, temperature sensor accuracy and temperature build-up in ex-vivo model.
1. Ex-vivo tissue study to evaluate the safety and temperature tissue penetration/depth profile
1. 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 DeviceInMode RF Pro System	Predicate DeviceInMode RF Multi SystemK201150
General
Product Code	GEI	GEI
Class	Class II	Class II
Manufacturer	InMode Ltd.	InMode Ltd.
	Subject DeviceInMode RF Pro System	Predicate DeviceInMode RF Multi SystemK201150
RF platform	InMode RF Pro System	InMode RF Multi System
Prescription or OTC	Prescription use only	Idem
Target Population	Adults requiring treatment asspecified in the indication for use	Idem
Anatomical sites	Body/facial parts requiringtreatment as specified in theindication for use	Idem
Environment Used	Hospital or Clinic setting	Idem
Device description /Design	The InMode RF Pro System is aline power, electro thermal, radiofrequency system with integraltemperature and impedancefeedback. The system is capable ofdelivering up to 65 watts of power.	Idem
Device components	The InMode RF Pro Systemconsists of the same followingcomponents as the InMode RFMulti System, with additionalapplicators as described in nexttable:• Electrosurgical Unit whichincludes the power supply, RFgenerator, controller and LCDtouch screen control and displaypanel• 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 - 50Hz100-240VAC2A	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 DeviceInMode RF Pro System	Predicate DeviceInMode RF Multi SystemK201150
Weight
System	20.0Kg [44.0lb]	32.0Kg [70.5lb]
RF Output Parameters
Maximum Output Power	65[W]	idem
Frequency	1MHz	idem
Crest Factor (RatedLoad)	$1.4\pm 2%$	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 withEnvironment and OtherDevices	InMode RF Pro System iscompliant with the IEC 60601-1-2(EMC Safety) standard	idem
Electrical Safety	Power Requirements:100-240 VAC 50-60 HzThe InMode RF Pro System iscompliant with the IEC 60601-1standard.	idem
Mechanical Safety	The InMode RF Pro System iscompliant with the IEC 60601-1standard.	idem
Chemical Safety	Not Applicable	idem
Thermal Safety	The InMode RF Pro System iscompliant with the IEC 60601-1standard.	idem
Radiation Safety	The InMode RF Pro System iscompliant with the IEC 60601-1-2(EMC Safety) standard	idem
TechnologicalCharacteristic	Subject DeviceInMode RF Pro System	Predicate DeviceInMode RF Multi SystemK201150
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: 60WInMode FRF 24 pin: 60WMorpheus8 12, 24, 40: 60WMorpheus8 T: 30W	idem
Tip needles penetrationdepth	FRACTORA 60 pin: 0.2mmInMode FRF 24 pin: 2.5mmMorpheus8 12 pin: 4.0mmMorpheus8 24, 40 pins: 7.0mmMorpheus8 T: 0.5mm	idem
General Aspects
Biocompatibility	Materials are biocompatible.	idem
Sterility	All tips are Gamma-sterilized	idem
Reprocessing	Handle to be reprocessed inaccordance with user manualinstructions. Tips are for single-use	idem

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Fractional RF Applicators

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Non-Invasive Applicators

TechnologicalCharacteristic	Subject DeviceInMode RF Pro System	Predicate DeviceInMode RF Multi SystemK201150
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 outputpower	BodyFX (WMBody): 50 [W]WMFace: 65 [W]MiniFX: 25 [W]	Idem

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TechnologicalCharacteristic	Subject DeviceInMode RF Pro System	Predicate DeviceInMode RF Multi SystemK201150
	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 inaccordance with user manualinstructions.	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.

Regulation Number and Section

§ 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.