(165 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on established technologies like bipolar radiofrequency and mechanical vibration.
Yes
The device is intended for the non-invasive treatment of mild to moderate facial wrinkles, which constitutes a therapeutic purpose.
No
The device is intended for non-invasive treatment of facial wrinkles and to provide massage, not for diagnosing medical conditions.
No
The device description explicitly states it 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... and the OxyGeneo Applicator utilizing mechanical vibration...". This indicates the device includes significant hardware components (console, applicators, RF technology, mechanical vibration motor) in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for non-invasive treatment of facial wrinkles and providing facial massage. These are therapeutic and cosmetic applications, not diagnostic testing performed on biological samples in vitro (outside the body).
- Device Description: The device uses radiofrequency energy and mechanical vibration for treatment and massage. It does not involve analyzing biological samples like blood, urine, or tissue.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's health status.
The device is clearly described as a non-invasive system for aesthetic and cosmetic treatments.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
PAY, ISA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
facial
Indicated Patient Age Range
adult users
Intended User / Care Setting
OTC use (estheticians or cosmeticians) / Esthetic and cosmetology clinics.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical (Bench) Performance Data:
The following 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 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4420 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.
0
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"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
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
2
3
Indications for Use
Submission Number (if known)
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.
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.
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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4
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
5
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:
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.
6
| 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)]
7
[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
8
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.
9
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 UXV
Predicate Device; Pollogen
Ltd. K220322 | GENEO X ELITE
Modified device;
Pollogen Ltd. | |
|-----------------------------------------|----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | 1) Device Classification and Clinical Characteristics | | | |
| (a) | Regulation Number | 21 CFR 878.4420 | 21 CFR 878.4420 –
TriPollar RF Applicator
21 CFR 890.5660 –
OxyGeneo Massage
Applicator | |
| (b) | Product Code | PAY | PAY – TriPollar RF
Applicator
ISA – OxyGeneo
Massage Applicator | |
| (c) | Class | Class II | idem | |
| (d) | Manufacturer | Pollogen Ltd. | idem | |
| (e) | Prescription or OTC | OTC use (Lay persons) | OTC use (estheticians or
cosmeticians) | |
| (f) | Target Population | Adults requiring treatment as
specified in the indications for
use. | idem | |
| (g) | Anatomical sites | Body parts requiring treatment
as specified in the indications
for use. | idem | |
| (h) | Environment Used | Home | Esthetic and cosmetology
clinics. | |
| (i) | Indications For Use | The STOP U Model UXV
device 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 device 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 | |
| | | STOP U Model UXV
Predicate Device;
Pollogen Ltd. K220322 | GENEO X
(ELITE)
Modified device;
Pollogen Ltd. | |
| 2) Device Technological Characteristics | | | | |
| (a) | Device description /
Design | The STOP U model UXV is
a line powered, portable,
software controlled, TriPollar
RF applicator. The TriPollar
RF applicator comprises the
system control unit and RF
generator. | The GENEO X is a line
powered, tabletop,
software controlled,
platform system,
including the TriPollar RF
applicator. The system
consists of the TriPollar
RF Applicator and the
OxyGeneo Applicator.
The TriPollar RF
Applicator comprises the
system control unit and
RF generator. | |
| (b) | Device components | The STOP U model UXV
device consists of the
following components:
The STOP U Model UXV
TriPollar RF Applicator unit,
containing the following
components:
Device head with
four treatment
electrodes and
temperature sensor RF Generator Control unit (CPU) Control panel which
contains: On/off button Skin temperature
ORANGE
indicator LED
light RF status
GREEN indicator
LED light | The GENEO X device
consists of the following
components:
The GENEO X TriPollar
RF Applicator unit,
containing the following
components:
Device head with
four treatment
electrodes and
temperature
sensor RF Generator Control unit
(CPU) Control panel
which contains: On/off button Skin
temperature
ORANGE
indicator LED
light | |
| | STOP U Model UXV
Predicate Device;
Pollogen Ltd. K220322 | GENEO X
(ELITE)
Modified device;
Pollogen Ltd. | | |
| | The STOP U Model UXV power supply unit | oRF status
GREEN/BLUE indicator LED light
oRF output power
The OxyGeneo Applicator massager
The GENEO X power supply unit and an adaptor
The 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 H
Weight: 85 gr | TriPollar RF Applicator:
Dimensions: 15mm W x 37mm D x 200mm H
Weight: 144 gr
Tabletop Console:
Dimensions: 510mm W x 195mm D x 418mm H
Weight: 9 Kg | | |
| (e) Output current | 1.5A | 2.5A (same as in reference OTC device STOP U K182774) | | |
| | | STOP U Model UXV
Predicate Device;
Pollogen Ltd. K220322 | GENEO X
(ELITE)
Modified device;
Pollogen Ltd. | |
| (f) | Energy levels | 1 | 1 | |
| (g) | Maximal RF output
power | $5.7 W \pm 10%$ | $6.0 W \pm 20%$ | |
| (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 UXV
device incorporates the
following safety features. All
personnel operating the
system should be familiar
with these features.
During activation, the
System performs a self-
test of the hardware. Temperature of the
treatment area is
constantly monitored
during the treatment. RF
energy delivery is
terminated when
temperature reaches the
Cut-off level. System starts at default
settings. LED indicators
positioned on the
applicator body provide
the operator with useful
treatment information on
treatment temperature | The GENEO X device
incorporates the following
safety features. All
personnel operating the
system should be familiar
with these features.
During activation,
the System performs
a self-test of the
hardware. Temperature of the
treatment area is
constantly monitored
during the treatment.
RF energy delivery is
terminated when
temperature reaches
the Cut-off level. System starts at
default settings. LED indicators
positioned on the
applicator body
provide the operator
with useful treatment
information on | |
10
11
12
13
| STOP U Model UXV
Predicate 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 |
14
| | | STOP U Model UXV
Predicate Device;
Pollogen Ltd. K220322 | GENEO X
(ELITE)
Modified device;
Pollogen Ltd. |
|-----|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | activation by
pressing the On/Off
button directly from
the applicator.
• The device GUI
provides useful
information and
messages including
alerts for improved
user compliance. |
| (b) | Compatibility with
Environment and
Other Devices | STOP U Model UXV is
compliant with the IEC
60601-1-2 (EMC Safety)
standard | idem |
| (c) | Electrical Safety | Power Requirements:
100-240 VAC 50-60 Hz
The STOP U Model UXV is
compliant with the IEC
60601-1 standard. | idem |
| (d) | Mechanical Safety | The STOP U Model UXV is
compliant with the IEC
60601-1 standard. | idem |
| (e) | Chemical Safety | N/A | N/A |
| (f) | Thermal Safety | The STOP U Model UXV is
compliant with the IEC
60601-1 standard. | idem |
| (g) | Radiation Safety | The STOP U Model UXV is
compliant with the IEC
60601-1-2 (EMC Safety)
standard. | idem |
| (h) | Biocompatibility | All of the device materials
that come in direct contact
with the human skin are
biocompatible.
Biocompatibility testing has
been completed for all
patient contacting material
on the finished device. | idem |
15
| STOP U Model UXV
Predicate Device;
Pollogen Ltd. K220322 | GENEO X
(ELITE)
Modified device;
Pollogen Ltd. |
|-----------------------------------------------------------------------------------------|---------------------------------------------------------|
| Biological testing passed
successfully and included
Cytotoxicity, 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.