The GENEO X ELITE system with the TriPollar RF Applicator is intended for use in the non-invasive treatment of mild to moderate facial wrinkles for adult users who have Fitzpatrick Skin Types I-IV.

The GENEO X ELITE system with the OxyGeneo Applicator is intended to provide massage by a mechanical vibration of an electrically powered applicator. The OxyGeneo treatment is suitable for all skin types.

Device Description

The GENEO X ELITE device is a non-invasive, tabletop console with a graphical user interface (GUI), which supports two applicator types: the TriPollar Radiofrequency (RF) Applicator utilizing bipolar radiofrequency technology for facial wrinkles treatments and the OxyGeneo Applicator utilizing mechanical vibration for facial massage sensation.

The GENEO X ELITE device is manufactured by Pollogen Ltd. Similar to the predicate device, the STOP U Model UXV device, the GENEO X ELITE device constitutes the same underlying TriPollar technology to employ bipolar RF energy in a non-invasive manner utilizing the TriPollar RF Applicator.

In addition to the TriPollar RF applicator the GENEO X ELITE device comprises the OxyGeneo Applicator. The OxyGeneo Applicator is an electrically powered massager utilizing mechanical vibration generated by an electrically powered motor housed in the applicator.

AI/ML Overview

The provided document is a 510(k) summary for the Pollogen Ltd. GENEO X ELITE device and does not contain detailed information about specific acceptance criteria or a dedicated study setup to prove device performance against those criteria in the way typically found for AI/ML devices.

However, based on the non-clinical and clinical performance data sections, and the general context of a 510(k) submission for an electrosurgical device, we can infer some "acceptance criteria" based on compliance with recognized standards and successful completion of various tests related to safety and functionality. The study described is primarily a Human Factors (Usability) study and various bench performance tests, rather than a clinical efficacy study with quantitative performance metrics.

Here's an attempt to structure the information based on your request, with the understanding that direct quantitative acceptance criteria and corresponding performance from a single study are not explicitly detailed for clinical efficacy in this document.

1. Table of Acceptance Criteria and Reported Device Performance

As the document is a 510(k) summary focused on substantial equivalence rather than a detailed clinical trial report, specific quantitative acceptance criteria for clinical effectiveness (e.g., specific reduction in wrinkle severity) and their statistically proven performance are not explicitly stated. Instead, "acceptance criteria" are inferred from compliance with recognized safety and performance standards and successful completion of bench and human factors testing.

Acceptance Criteria (Inferred from Compliance & Testing)	Reported Device Performance (Summary)
I. Safety & Functionality (Bench Testing)
Electrical Safety & Essential Performance (IEC 60601-1)	Complies with requirements of IEC 60601-1 and relevant amendments.
EMC Performance (IEC 60601-1-2)	Complies with requirements of IEC 60601-1-2 (EMC emissions and immunity).
Software Verification & Validation	Successfully completed.
Power Control & RF Accuracy	Successfully completed. Max RF output power: $6.0 W \pm 20%$. RF Frequency: $1 MHz \pm 10%$.
Overheating Testing	Successfully completed. RF energy delivery is terminated when temperature reaches Cut-off level.
Biocompatibility (Cytotoxicity, Irritation, Sensitization)	Passed successfully for all patient-contacting materials.
Mechanical Safety (IEC 60601-1)	Complies with requirements of IEC 60601-1.
Thermal Safety (IEC 60601-1)	Complies with requirements of IEC 60601-1.
Radiant Safety (IEC 60601-1-2)	Complies with requirements of IEC 60601-1-2.
Labeling Verification & Validation	Successfully completed.
Service Life Analysis	Successfully completed.
Transportation and Environmental Testing	Successfully completed.
II. Usability (Human Factors Validation Testing)
User Interface & RF Applicator Treatment Protocol Ease of Use & Effectiveness	Demonstrated GENEO X device is easy to operate. Workflow, training materials, and instructions validated.
Adequacy of User Manual (Instructions for Use)	User manual found adequate for instructing users on operation and maintenance.
Mitigation of Residual Usability Risks	Risks mitigated through validation in a real-world environment.

2. Sample Sizes Used for Test Set and Data Provenance

Human Factors Validation Testing (Phase II):
- Sample Size: The document does not explicitly state the number of participants (users or cases) in the Human Factors Validation Testing (Phase II). It only mentions that the study involved "use of the device by the device target users (estheticians / cosmeticians) and performing device operation and knowledge tasks."
- Data Provenance: The document states that the GENEO X Human Factors (Usability) validation test further validated the device "in a real-world environment." Phase I (formative assessment) was performed "on the GENEO X TriPollar RF device (precursor to the GENEO X) in the EU (Belgium and Switzerland) and Canada." The Phase II validation study's specific location is not detailed beyond "real-world environment." This study is prospective, as it involves testing with target users.

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

For the Human Factors Validation Testing, "ground truth" would relate to the assessment of usability and the effectiveness of training materials. The document implies that "target users (estheticians / cosmeticians)" performed the tasks and their performance/feedback constituted the data for assessing usability. No explicit mention of independent "experts" establishing a separate "ground truth" for usability, outside of the direct user experience and observation during the study, is made.

4. Adjudication Method for the Test Set

The document does not describe a clinical performance study with an adjudication method (like 2+1, 3+1). The Human Factors study's assessment method is not detailed in terms of adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is described for clinical efficacy. The Human Factors study is not an MRMC study for clinical outcomes, but rather for usability. The document focuses on substantial equivalence to a predicate device based on similar technology, safety, and performance, not on demonstrating improved effectiveness over human readers or other devices.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

This device is an electrosurgical device for aesthetic use, involving a human operator (esthetician/cosmetician). It is not an AI/ML diagnostic or predictive algorithm, so the concept of "standalone performance" for an algorithm without human-in-the-loop does not apply in the typical sense. The device's operation inherently involves a human user.

7. Type of Ground Truth Used

For Bench Performance Data: The "ground truth" for technical specifications (e.g., RF output power, frequency, electrical safety) is established by measurements against recognized international standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2).
For Human Factors Validation Testing: The "ground truth" is derived from user performance, observations, and feedback from the device's target users (estheticians/cosmeticians) as they interact with the device and training materials in a simulated real-world environment.

8. Sample Size for the Training Set

This document does not describe an AI/ML device in the context of a "training set" for an algorithm that learns from data. Therefore, the concept of a training set sample size is not applicable. The device design and safety features are based on engineering principles and compliance with standards, not machine learning training.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the context of an AI/ML algorithm learning.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 7, 2024

Pollogen Ltd. % Amit Goren Head of Regulatory Affairs A. Stein Regulatory Affairs Consulting Company Ltd. 18 Hata'as St. Kfar Saba, 4442518 Israel

Re: K233766

Trade/Device Name: Geneo X Elite Regulation Number: 21 CFR 878.4420 Regulation Name: Electrosurgical Device For Over-The-Counter Aesthetic Use Regulatory Class: Class II Product Code: PAY Dated: November 14, 2023 Received: November 24, 2023

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 (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/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.

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"

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(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.

Long H. Chen-S Digitally signed by Long H.Chen-S. 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

Submission Number (if known)

K233766

Device Name

GENEO X ELITE

Indications for Use (Describe)

The GENEO X ELITE system with the TriPollar RF Applicator is intended for use in the non-invasive treatment of mild to moderate facial wrinkles for adult users who have Fitzpatrick Skin Types I-IV.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

GENEO X ELITE DEVICE

510(k) Number K233766

Applicant Name:

Company Name:
Address:

Pollogen Ltd. 6 Kaufman St. POB 50320 Tel-Aviv, 6801298 Israel Tel: +972-3-5104110 Fax: +972-3-5104112 E-mail: amit(@asteinrac.com

Contact Person:

Official Correspondent:	Amit Goren
Company Name:	A. Stein – Regulatory Affairs Consulting Ltd.
Address:	18 Hata'as Str.,Kfar Saba 4442518, Israel
	Tel: +972-9-7670002
	Fax: +972-9-7668534
	E-mail: amit@asteinrac.com

Date Prepared: April 07, 2024

Trade Name: GENEO X ELITE Device

Classification Name: Main system platform:

21 CFR 878.4420, Class II, PAY

System Applicators:

The GENEO X device TriPollar RF Applicator unit: 21 CFR 878.4420, Class II, PAY

The OxyGeneo Applicator unit: 21 CFR 890.5660, Class I, ISA

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Classification: Class II Medical Device

Predicate Device:

The subject device is substantially equivalent to the following predicate device:

Manufacturer	Device	510(k) No.
Pollogen Ltd.	STOP U Model UXV	K220322

Device Description:

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General Specifications Conditions for Operation:
Weight:	~9 Kg
Overall Dimensions:	418mm x 510mm x 223mm (H x W x D)
Input Voltage of Power Supply:	100-240V~50/60Hz,0.8-1.5A
Output Power Rating of Power Supply:	24VDC, 2.5A
Performance Specifications
TriPollar RF Applicator Output Power	6W @ 200 OHM
TriPollar RF Applicator RF Frequency	1MHz
Massager Applicator speed range	300 - 1800±10% RPM
Environmental Conditions for Operation:
Operating Temperature:	+5°C - +30°C
Operating Humidity:	20 - 80% RH
Atmospheric Pressure:	80 - 106 KPa
Operating Altitude:	2000 above sea level
Conditions for Transportation and Storage:
Transport and Storage Temperature:	-20°C - +60°C
Transport and Storage Humidity:	5-90% RH
Atmospheric Pressure:	50 - 106 KPa
Preparation Gel Storage Conditions:
Operating Temperature range	+5°C - +30°C

Following are the GENEO X ELITE device specifications:

Intended Use/Indication for Use:

The GENEO X ELITE device with the TriPollar RF Applicator is intended for use in the non-invasive treatment of mild to moderate facial wrinkles for adult users who have Fitzpatrick Skin Types I-IV.

The GENEO X ELITE device with the OxyGeneo Applicator is intended to provide massage by a mechanical vibration of an electrically powered applicator. The OxyGeneo treatment is suitable for all skin types.

Performance Standards:

The GENEO X ELITE device complies with the following recognized consensus standards:

[Rec. Number 19-46] ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012 C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 MOD) [Including Amendment 2 (2021)]

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[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 19-36] 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION 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

[Rec. Number 13-79] IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software - Software life cycle processes

All the requirements of these standards were met. No adaptations were made to any of the test methods recommended in the standard. There were no applied deviations from the standard.

Non-Clinical (Bench) Performance Data:

The following validation activities were performed:

Software Verification and Validation Testing .
Electrical safety and EMC testing
Transportation and Environmental Testing
Power control and RF accuracy testing ●
Overheating testing .
. Labeling Verification and Validation Testing
Biocompatibility evaluation
Service Life Analysis

All of the validation activities were performed using the same testing techniques and principles as performed using the predicate or reference devices. The results of the above

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listed validation activities conclude that the GENEO X Elite device is safe and effective for its intended use and user population (both users and patients) and that the modified device is substantially equivalent to the predicate device.

Animal Performance Data / Histology Data:

Not Applicable

Clinical Performance Data:

Human Factors Validation Testing with the GENEO X ELITE device was performed to assess the user interface and RF applicator treatment protocol, including selection of the TriPollar RF applicator, turning on the GENEO X main unit, choosing basic system settings, providing treatment and cleaning, in the setting in which the device is intended to be used. The GENEO X workflow, training materials, and instructions were developed through formative assessment (Phase I) on the GENEO X TriPollar RF device (precursor to the GENEO X) in the EU (Belgium and Switzerland) and Canada.

The current GENEO X human factors (Usability) validation test further validated the GENEO X device and associated training materials, in a real-world environment in order to mitigate the residual usability risks (Phase II).

The Human Factors (Usability) study performed utilizing the GENEO X device was designed based on the Human Factors (Usability) study design conducted utilizing the reference device, the STOP U OTC device (K182744).

All aspects of the Human Factors / Usability study design were virtually identical in the GENEO X HF Study and in the previous STOP U HF study conducted with the reference device and demonstrate the substantial equivalence of the device to the main and reference devices and support the safety and effectiveness of the device.

Biocompatibility

All of the modified device materials which come in direct contact with the patient skin are biocompatible and identical to the materials used in the manufacturing of the predicate device or in other FDA cleared devices. Biocompatibility testing has been completed for all patient contacting material on the finished device. Biological testing passed successfully and included Cytotoxicity, Irritation, and Sensitization testing.

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Substantial Equivalence:

The following tables provide comparison information for the GENEO X ELITE device and its primary predicate device; the STOP U Model UXV device.

		STOP U Model UXVPredicate Device; PollogenLtd. K220322	GENEO X ELITEModified device;Pollogen Ltd.
	1) Device Classification and Clinical Characteristics
(a)	Regulation Number	21 CFR 878.4420	21 CFR 878.4420 –TriPollar RF Applicator21 CFR 890.5660 –OxyGeneo MassageApplicator
(b)	Product Code	PAY	PAY – TriPollar RFApplicatorISA – OxyGeneoMassage Applicator
(c)	Class	Class II	idem
(d)	Manufacturer	Pollogen Ltd.	idem
(e)	Prescription or OTC	OTC use (Lay persons)	OTC use (estheticians orcosmeticians)
(f)	Target Population	Adults requiring treatment asspecified in the indications foruse.	idem
(g)	Anatomical sites	Body parts requiring treatmentas specified in the indicationsfor use.	idem
(h)	Environment Used	Home	Esthetic and cosmetologyclinics.
(i)	Indications For Use	The STOP U Model UXVdevice is intended for use inthe non-invasive treatment ofmild to moderate facialwrinkles for adult users whohave Fitzpatrick Skin Types I-IV	The GENEO X device isintended for use in thenon-invasive treatment ofmild to moderate facialwrinkles for adult userswho have Fitzpatrick SkinTypes I-IV
		STOP U Model UXVPredicate Device;Pollogen Ltd. K220322	GENEO X(ELITE)Modified device;Pollogen Ltd.
2) Device Technological Characteristics
(a)	Device description /Design	The STOP U model UXV isa line powered, portable,software controlled, TriPollarRF applicator. The TriPollarRF applicator comprises thesystem control unit and RFgenerator.	The GENEO X is a linepowered, tabletop,software controlled,platform system,including the TriPollar RFapplicator. The systemconsists of the TriPollarRF Applicator and theOxyGeneo Applicator.The TriPollar RFApplicator comprises thesystem control unit andRF generator.
(b)	Device components	The STOP U model UXVdevice consists of thefollowing components:The STOP U Model UXVTriPollar RF Applicator unit,containing the followingcomponents:Device head withfour treatmentelectrodes andtemperature sensor RF Generator Control unit (CPU) Control panel whichcontains: On/off button Skin temperatureORANGEindicator LEDlight RF statusGREEN indicatorLED light	The GENEO X deviceconsists of the followingcomponents:The GENEO X TriPollarRF Applicator unit,containing the followingcomponents:Device head withfour treatmentelectrodes andtemperaturesensor RF Generator Control unit(CPU) Control panelwhich contains: On/off button SkintemperatureORANGEindicator LEDlight
	STOP U Model UXVPredicate Device;Pollogen Ltd. K220322	GENEO X(ELITE)Modified device;Pollogen Ltd.
	The STOP U Model UXV power supply unit	oRF statusGREEN/BLUE indicator LED lightoRF output powerThe OxyGeneo Applicator massagerThe GENEO X power supply unit and an adaptorThe device tabletop console contains:• A touchscreen with a mounted cradle bar (on the front panel)• Applicator cradles (on front panel) located on the cradle bar and connectors (on rear panel)
(c) Performance specifications	Input power: 100-240V, 50-60 Hz, 0.4A	Input power: 100-240V, 50-60 Hz, 1.5A (same as in reference OTC device STOP U K182774)
(d) Physical specifications	Dimensions: 32mm W x 51mm D x 134mm HWeight: 85 gr	TriPollar RF Applicator:Dimensions: 15mm W x 37mm D x 200mm HWeight: 144 grTabletop Console:Dimensions: 510mm W x 195mm D x 418mm HWeight: 9 Kg
(e) Output current	1.5A	2.5A (same as in reference OTC device STOP U K182774)
		STOP U Model UXVPredicate Device;Pollogen Ltd. K220322	GENEO X(ELITE)Modified device;Pollogen Ltd.
(f)	Energy levels	1	1
(g)	Maximal RF outputpower	$5.7 W \pm 10%$	$6.0 W \pm 20%$
(h)	RF Frequency	$1 MHz \pm 10%$	idem
(i)	Total Power Density(fluence)	$5.7 W/cm^2 \pm 10%$	$6.0 W/cm^2 \pm 20%$
(j)	Pulse Duration	Continuous	idem
(k)	Waveform	Biphasic	idem
(l)	Wave Shape	Sinusoid	idem
	3) Safety and Adherence to Consensus Standards
(a)	Safety features	The STOP U Model UXVdevice incorporates thefollowing safety features. Allpersonnel operating thesystem should be familiarwith these features.During activation, theSystem performs a self-test of the hardware. Temperature of thetreatment area isconstantly monitoredduring the treatment. RFenergy delivery isterminated whentemperature reaches theCut-off level. System starts at defaultsettings. LED indicatorspositioned on theapplicator body providethe operator with usefultreatment information ontreatment temperature	The GENEO X deviceincorporates the followingsafety features. Allpersonnel operating thesystem should be familiarwith these features.During activation,the System performsa self-test of thehardware. Temperature of thetreatment area isconstantly monitoredduring the treatment.RF energy delivery isterminated whentemperature reachesthe Cut-off level. System starts atdefault settings. LED indicatorspositioned on theapplicator bodyprovide the operatorwith useful treatmentinformation on

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STOP U Model UXVPredicate Device;Pollogen Ltd. K220322	GENEO X(ELITE)Modified device;Pollogen Ltd.
The device complies with applicable electrical and mechanical standard requirements according to IEC 60601-1 and with the applicable RF standard IEC 60601-2-2. The device complies with applicable EMC emissions and immunity standard requirements according to IEC 60601-1-2.	treatment temperature and RF emission. The device complies with applicable electrical and mechanical standard requirements according to IEC 60601-1 and with the applicable RF standard IEC 60601-2-2. The device complies with applicable EMC emissions and immunity standard requirements according to IEC 60601-1-2. System has unique password to avoid device operation by unauthorized personnel. The TriPollar RF power cannot be activated unless the designated applicator has been connected to the System. Changes in the TriPollar RF applicator treatment duration will cause the device to stop and enter stand-by mode. The operator must select the desired treatment duration from the TriPollar Menu and resume applicator power

STOP U Model UXVPredicate Device;Pollogen Ltd. K220322

GENEO X(ELITE)Modified device;Pollogen Ltd.

The device complies with applicable electrical and mechanical standard requirements according to IEC 60601-1 and with the applicable RF standard IEC 60601-2-2. The device complies with applicable EMC emissions and immunity standard requirements according to IEC 60601-1-2.

treatment temperature and RF emission. The device complies with applicable electrical and mechanical standard requirements according to IEC 60601-1 and with the applicable RF standard IEC 60601-2-2. The device complies with applicable EMC emissions and immunity standard requirements according to IEC 60601-1-2. System has unique password to avoid device operation by unauthorized personnel. The TriPollar RF power cannot be activated unless the designated applicator has been connected to the System. Changes in the TriPollar RF applicator treatment duration will cause the device to stop and enter stand-by mode. The operator must select the desired treatment duration from the TriPollar Menu and resume applicator power

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		STOP U Model UXVPredicate Device;Pollogen Ltd. K220322	GENEO X(ELITE)Modified device;Pollogen Ltd.
			activation bypressing the On/Offbutton directly fromthe applicator.• The device GUIprovides usefulinformation andmessages includingalerts for improveduser compliance.
(b)	Compatibility withEnvironment andOther Devices	STOP U Model UXV iscompliant with the IEC60601-1-2 (EMC Safety)standard	idem
(c)	Electrical Safety	Power Requirements:100-240 VAC 50-60 HzThe STOP U Model UXV iscompliant with the IEC60601-1 standard.	idem
(d)	Mechanical Safety	The STOP U Model UXV iscompliant with the IEC60601-1 standard.	idem
(e)	Chemical Safety	N/A	N/A
(f)	Thermal Safety	The STOP U Model UXV iscompliant with the IEC60601-1 standard.	idem
(g)	Radiation Safety	The STOP U Model UXV iscompliant with the IEC60601-1-2 (EMC Safety)standard.	idem
(h)	Biocompatibility	All of the device materialsthat come in direct contactwith the human skin arebiocompatible.Biocompatibility testing hasbeen completed for allpatient contacting materialon the finished device.	idem

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STOP U Model UXVPredicate Device;Pollogen Ltd. K220322	GENEO X(ELITE)Modified device;Pollogen Ltd.
Biological testing passedsuccessfully and includedCytotoxicity, Irritation, and
Sensitization testing.

Comparison Discussion:

The GENEO X device is a desktop, computerized, software-controlled device comprising a console with a touchscreen, applicator cradles, and two treatment applicators, the TriPollar RF applicator intended for treatment of mild to moderate wrinkles and the OxyGeneo mechanical massager applicator.

The intended use of the GENEO X device is identical to the intended use of the predicate STOP U Model UXV device (K220322), i.e. treatment of mild to moderate facial wrinkles. The GENEO X device is an OTC device, designed for qualified estheticians or cosmeticians use for use in esthetic and cosmetology clinics. It is not intended for use by laypersons and will not be sold to retail stores or pharmacies, but directly to qualified estheticians or cosmeticians.

The GENEO X TriPollar RF applicator is based on the same underlying RF technology as employed in the predicate STOP U Model UXV TriPollar RF applicator device. The mechanism of action and mechanism of operation are essentially identical to that of the predicate device. Minor modifications were made in the GENEO X TriPollar RF applicator, which do not raise new questions of safety or effectiveness. The modified specifications are extremely slight and therefore, the GENEO X TriPollar RF applicator is substantially equivalent to the specifications of the STOP U Model UXV predicate device.

The addition of the console with the touchscreen and the applicator cradles also do not raise new questions of safety or effectiveness. The subject device and predicate device present almost identical performance specifications (for the specified indications for use)

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and integrate a set of similar safety features. The GENEO X device presents some additional safety features mainly related to the information that is provided to the user in the GUI. The minor differences in the technological characteristics between the subject device and predicate device do not raise new safety or effectiveness concerns. Furthermore, the subject device underwent performance testing including software validation testing, electrical and mechanical safety testing, EMC testing and specific bench testing, including RF output power testing and thermal overheating validation testing.

All of the above-mentioned performance test protocols were designed and performed in the same manner as the predicate device or the reference devices and the test results demonstrated that the GENEO X device has successfully passed the tests and that all of the device requirements were met.

Furthermore, the GENEO X device was also tested for human factors and usability. The human factors study was also designed in the same manner as the previous human factors study performed with the STOP U OTC reference device (K182774). The study involved use of the device by the device target users (estheticians / cosmeticians) and performing device operation and knowledge tasks. The human study / usability study results demonstrated that the GENEO X device is easy to operate, and the user manual is adequate for its purpose of instructing users how to operate and maintain the device.

Consequently, it can be concluded that the GENEO X device is substantially equivalent to the predicate, STOP U Model UXV device, (FDA-cleared in 510(k) K220322) and therefore, may be legally marketed in the USA.

Regulation Number and Section

§ 878.4420 Electrosurgical device for over-the-counter aesthetic use.

(a)
Identification. An electrosurgical device for over-the-counter aesthetic use is a device using radiofrequency energy to produce localized heating within tissues for non-invasive aesthetic use.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical performance data must demonstrate that the device meets all design specifications and performance requirements. The following performance characteristics must be tested: Over-heating, power accuracy radiofrequency, pulse cycle, waveform, pulse duration, and device characterization parameters.
(2) Label comprehension and self-selection performance evaluation must demonstrate that the intended over-the-counter users can understand the package labeling and correctly choose the device for the indicated aesthetic use.
(3) Usability performance evaluation must demonstrate that the over-the-counter user can correctly use the device, based solely on reading the directions for use, to treat the indicated aesthetic use.
(4) Clinical performance evaluation must demonstrate that the device performs as intended under anticipated conditions of use to achieve the intended aesthetic results.
(5) The patient-contacting components of the device must be demonstrated to be biocompatible.
(6) Instructions for cleaning the device must be validated.
(7) Performance data must be provided to demonstrate the electromagnetic compatibility and electrical safety, including the mechanical integrity, of the device.
(8) Software verification, validation, and hazard analysis must be performed.
(9) Labeling must include:
(i) Warnings, precautions, and contraindications to ensure the safe use of the device for the over-the-counter users.
(ii) A statement that the safety and effectiveness of the device's use for uses other than the indicated aesthetic use are not known.
(iii) A summary of the clinical information used to establish effectiveness for each indicated aesthetic usage and observed adverse events.