2 Face / Face Evolution

K171821 · Heat IN A Click · NFO · Apr 26, 2018 · Neurology

Device Facts

• Record ID: K171821
• Device Name: 2 Face / Face Evolution
• Applicant: Heat IN A Click
• Product Code: NFO · Neurology
• Decision Date: Apr 26, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

2 Face / Face Evolution is a hand-held device for over-the counter aesthetic purposes. (1) The EMS mode is indicated for facial stimulation; (2) The Photon mode: The red light is intended for the treatment of periorbital wrinkles and the blue light is intended for the treatment of the mild to moderate inflammatory acne.

Device Story

2 Face / Face Evolution is a handheld, multifunctional beauty instrument for home use. It features two modes: EMS (microcurrent) and Photon (LED light). EMS mode delivers microcurrents via a treatment probe to provide facial stimulation; requires conductive gel. Photon mode emits red light (630nm) for periorbital wrinkle treatment and blue light (415nm) for mild to moderate inflammatory acne. Device includes a main unit, charger, and manual. It provides 4 intensity levels and features automatic shut-off. Users operate the device by applying the probe to the face. Output is controlled by an internal microprocessor. Benefits include aesthetic facial toning and skin condition management.

Clinical Evidence

Bench testing only. Compliance demonstrated via AAMI/ANSI/ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), IEC 60601-1-2 (EMC), IEC 60601-1-11 (home healthcare), IEC 60601-2-57 (non-laser light source), IEC 60601-1-6 (usability), IEC 60601-2-10 (nerve/muscle stimulators), IEC 62133 (battery safety), IEC 62366 (usability engineering), and IEC 62304 (software life-cycle).

Technological Characteristics

Materials: ABS plastic and stainless steel. Sensing/Actuation: Microcurrent stimulation and LED light emission (Red 630nm, Blue 415nm). Energy: DC 3.7V 2200mAh battery. Form factor: Handheld (158mm x 56mm x 51.5mm). Connectivity: Standalone. Software: Microprocessor-controlled. Sterilization: Not applicable (non-sterile).

Indications for Use

Indicated for individuals with periorbital wrinkles and individuals with mild to moderate inflammatory acne for over-the-counter aesthetic facial stimulation and light-based treatment.

Regulatory Classification

Identification

A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

Predicate Devices

• NUFACE® Plus (K103472)
• LED Phototherapy (PL-120) (K162098)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.

April 26, 2018

Heat In A Click % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road Guangzhou Science Park Guangzhou, Guangdong 510006 CN

Re: K171821

Trade/Device Name: 2 Face / Face Evolution Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NFO, OHS, OLP Dated: March 22, 2018 Received: March 26, 2018

Dear Cassie Lee:

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. 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Vivek J. Pinto -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K171821

Device Name 2 Face / Face Evolution

Indications for Use (Describe)

2 Face / Face Evolution is a hand-held device for over-the counter aesthetic purposes.

(1) The EMS mode is indicated for facial stimulation;

(2) The Photon mode: The red light is intented for the treatment of periorbital wrinkles and the blue light is intended for the treatment of the mild to moderate inflammatory acne.

| Type of Use (Select one or both, as applicable) | <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|-------------------------------------------------|-----------------------------------------------------------------|
|-------------------------------------------------|-----------------------------------------------------------------|

_ | Prescription Use (Part 21 CFR 801 Subpart D)

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

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## Chapter 5. 510(k) Summary

## 510(k) Summary

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

## Date of the summary prepared: April 26, 2018

## 1. Submitter's Information

Company Name: Heat In A Click Address: 1975 Tigertail Blvd Dania Florida 33034 USA Phone: [phone] Fax No.: 1(954)320-7984 Contact Person (including title): Guy Levi (CEO) E-mail: [e-mail]

## Application Correspondent:

Contact Person: Ms. Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Address: Suite 306, Kecheng Mansion, No.121 Science Road, Guangzhou Science Park, Guangzhou 510663, China Tel: [phone] Email: [e-mail]

## 2. Subject Device Information

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Heat In A Click Sponsor: 2 Face / Face Evolution, Model: 2 Face / Face Evolution Subject Device: Document Name: FDA 510(k) Submission Report

Type of 510(k): Traditional

Common Name: Stimulator, Transcutaneous Electrical, Aesthetic Purposes; Light Based Over the Counter Wrinkle Reduction, over-the counter powered light based laser for acne Review Panel: Neurology; General & Plastic Surgery

Trade Name: 2 Face / Face Evolution (Model: 2 Face / Face Evolution)

Classification Name: Stimulator, Transcutaneous Electrical, Aesthetic Purposes; Light Based Over the

Counter Wrinkle Reduction, over-the counter powered light based laser for acne

Review Panel: Neurology: General & Plastic Surgery

Product code: NFO, OHS, OLP

Regulation Number: 882.5890, 878.4810

Requlation Class: 2

## 3. Predicate Device Information

| Sponsor | Carol Cole Company | Li-Tek Electronics<br>Technologies |
|-----------------------|--------------------|------------------------------------|
| Device Name and Model | NUFACE® Plus | LED Phototherapy (PL-120) |
| 510(k) Number | K103472 | K162098 |
| Product Code | NFO | OLP, OHS |
| Regulation Number | 882.5890 | 878.4810 |
| Regulation Class | II | II |

#### 4. Device Description

2 Face / Face Evolution (Model: 2 Face / Face Evolution) is consists of a Main Unit, conductive gel, charger and user manual, it's a multifunctional comprehensive beauty instrument. It's combined with the most effective two kinds of techniques of internationally recognized skin care:

The EMS Mode is intended for facial stimulation for aesthetic purposes. It produces microcurrent discharged through the EMS Mode treatment probe. Microcurrent is an aesthetic modality providing electric current in millionths of an ampere. The EMS mode is indicated for aesthetic facial stimulation and requires the use of conductive gel. Photon mode: The red light is intended for the treatment of periorbital wrinkles, and the blue light is intended for the treatment of the mild to moderate inflammatory acne. It emits energy in the red spectrum for the treatment of periorbital wrinkles. The PHOTON Mode treatment probe is designed for contact with the face. The device continually pulses the light output, and provides 4 kinds of output intensity level.

## 5. Intended Use / Indications for Use

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| Sponsor: | Heat In A Click |
|-----------------|---------------------------------------------------------|
| Subject Device: | 2 Face / Face Evolution, Model: 2 Face / Face Evolution |
| Document Name: | FDA 510(k) Submission Report |

2 Face / Face Evolution is a hand-held device for over-the counter aesthetic purposes.

(1) The EMS mode is indicated for facial stimulation;

(2) The Photon mode: The red light is intended for the treatment of periorbital wrinkles and the blue light is intended for the treatment of the mild to moderate inflammatory acne.

## 6. Test Summary

2 Face / Face Evolution has been evaluated the safety and performance by lab bench testing as following:

- AAMI / ANSI / ISO 10993-5:2009(R) 2014, biological evaluation of medical devices -- part 5: tests for � in vitro cytotoxicity. (Biocompatibility).
- ◆ ISO 10993-10 Third Edition 2010-08-01, biological evaluation of medical devices - part 10: tests for irritation and skin sensitization. (Biocompatibility).
- � IEC / EN 60601-1-2: 2014-02, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - collateral standard: Electromagnetic Compatibility.
- � IEC 60601-2-11 (First Edition):2010, Medical electrical equipment -- part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- � IEC 60601-2-57 (First Edition): 2011 for use in conjunction with IEC 60601-1:2005, Medical electrical equipment -- Part 2: Particular requirements for the basic safety and essential performance of nonlaser light source equipment intended for therapeutic, monitoring and cosmetic/aesthetic use
- ◆ IEC 60601-1-6: 2010 (Third Edition), Medical electrical equipment - Part 1-6 General requirements for safety - Collateral Standard: Usability
- � IEC 60601-2-10: 2012 (Second Edition), medical electrical equipment -- part 2-10: particular requirements for the basic safety and essential performance of nerve and muscle stimulators. (Neurology)
- � IEC 62133 Edition 2.0 2012-12, Secondary Cells And Batteries Containing Alkaline Or Other Non-Acid Electrolytes - Safety Requirements For Portable Sealed Secondary Cells, And For Batteries Made From Them, For Use In Portable Applications
- � IEC 62366: 2007 (First Edition) + A1: 2014, Medical devices - Application of usability engineering to medical devices
- � IEC 62304: 2006 (First Edition), Medical device software, Software life- cycle processes.

## 7. Comparison to predicate device and conclusion

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Compare with predicate device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between subject device and predicate device do not raise and new questions of safety or effectiveness.

| Elements of<br>Comparison | Subject Device | Predicate Device | Remark | | NiMH batteries | Li battery | Note 2 | |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|--------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------|--------------|
| Manufacturer | Heat In A Click | Carol Cole<br>Company | -- | Average DC current through electrodes when device is on but no pulses are being applied | 0A | 0A | -- | SE |
| Device Name<br>and Model | 2 Face / Face<br>Evolution | NuFace® Plus | -- | Number of Output channels | 2 | 1 | -- | SE<br>Note 2 |
| 510(k) Number | K171821 | K103472 | -- | Regulated Current or Regulated Voltage? | Both | Both | -- | SE |
| Product Code | NFO, OHS, OLP | NFO | SE | Software/Firmware/Microprocessor Control? | Yes | Yes | Yes | SE |
| Indications for<br>Use | 2 Face / Face<br>Evolution is a hand-<br>held device for over-<br>the counter aesthetic<br>purposes.<br>(1) The EMS mode is<br>indicated for facial<br>stimulation;<br>(2) The Photon mode:<br>The red light is<br>intended for the<br>treatment of periorbital<br>wrinkles and the blue<br>light is intended for the<br>treatment of the mild to<br>moderate inflammatory<br>acne. | The NuFace® Plus<br>Facial Toning<br>Device is intended<br>for facial<br>stimulation and is<br>indicated for over-<br>the-counter<br>cosmetic use. | SE<br>Note 1 | Automatic Overload Trip? | No | No | Yes | SE |
| Anatomical<br>Sites | Entire Face | Entire Face | SE | Automatic Shut Off | Yes | Yes | Yes | SE |
| Design | Hand-held device | Hand-held device | SE | User Override Control? | Yes | Yes | Yes | SE |
| Target<br>Population | Individuals with<br>periorbital wrinkles,<br>Individuals with mild<br>to moderate<br>inflammatory acne | Individuals seeking<br>facial simulation for<br>aesthetic purposes | SE | Indicator | EMS Mode intensity Indicator lights, Photon Mode working indicator lights, Photon Mode Indicator lights, Charging Indicator | Indicates on/off status, low battery and voltage / current level. | -- | SE<br>Note 2 |
| Environment of<br>Use | Home | Home | SE | Time Range (minutes) | EMS Mode (5 minutes) Photon Mode (5~7 minutes) | 21 minutes | 3 minutes per target area; 2 treatment per week for 6 weeks | SE<br>Note 2 |
| Method of Line<br>current<br>Isolation | Type BF | Type BF | SE | Wavelengths | Red Light (630nm±3nm Wavelength), Blue Light (415nm±3nm Wavelength) | -- | Blue light:<br>415nm±3nm<br>Red light:<br>630nm±3nm | SE<br>Note 3 |
| Main Unit<br>Weight | 200g | 9oz without<br>charging base | SE<br>Note 2 | LED power | 0.1 W | -- | 0.1 W | SE |
| Dimensions of<br>device (inch)[W<br>x LxD] | 158mm*56mm*51.5<br>mm | 3"x 5.25"x 1.25" | SE<br>Note 2 | Energy emitted during the treatment | 1050J | -- | 1080J | SE<br>Note 3 |
| Housing<br>Materials of<br>main unit | ABS Plastic &<br>Stainless Steel | Thermo Plastic | SE<br>Note 2 | The distance between the LEDs to treatment treatment surface | 2-3 cm | -- | 2-3 cm | SE |
| Power Source | DC 3.7V 2200mAh | 4 rechargeable AA | SE | Irradiation area | 26cm²±5% | -- | 30cm²±5% | SE<br>Note 3 |

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| Sponsor: | Heat In A Click |
|-----------------|---------------------------------------------------------|
| Subject Device: | 2 Face / Face Evolution, Model: 2 Face / Face Evolution |
| Document Name: | FDA 510(k) Submission Report |

| Irradiances | Red light: 73.26<br>mW/cm²±10%<br>Blue light: 64.10<br>mW/cm²±10% | -- | Red light: 80<br>mW/cm² ±10%<br>Blue light: 65<br>mW/cm²±10% | SE<br>Note 4 |
|----------------------------------------|-------------------------------------------------------------------|------------------------------------------------------|--------------------------------------------------------------|--------------|
| Waveform and<br>Shape | Pulsed Biphasic,<br>Modulated Square | Pulsed<br>MonoPhasic,<br>Modulated Square | -- | SE<br>Note 3 |
| Maximum<br>Output Voltage<br>(+/- 10%) | 310mV @ 500Ω<br>1.16V @ 2KΩ<br>5.56V @ 10KΩ | 137 mV @ 500Ω<br>769 mV @ 2 ΚΩ<br>3.82 V @ 10 kΩ | -- | SE<br>Note 3 |
| Maximum<br>Output Current<br>(+/- 10%) | 620µA @ 500Ω<br>580μΑ @ 2KΩ<br>556μΑ @ 10KΩ | 274μA @ 500Ω<br>387μΑ @ 2KΩ<br>283μΑ @ 10kΩ | -- | SE<br>Note 3 |
| Maximum<br>Phase Charge | 26.31μC @ 500Ω | 23.06μC @ 500Ω | -- | SE<br>Note 3 |
| Maximum<br>Current Density | 0.330mA/cm² @500Ω<br>(The Minimum<br>Electrode Size:<br>2.91cm²) | 0.419<br>mA/cm²@500Ω | -- | SE<br>Note 3 |
| Maximum<br>Power Density | 4.34μW/cm² @500Ω<br>(The Minimum<br>Electrode Size:<br>2.91cm²) | 3.22µW/cm²@500<br>Ω | -- | SE<br>Note 3 |
| Pulse Duration | 60ms | 119ms | -- | SE<br>Note 3 |
| Frequency | 8.333Hz | 8.4Hz | -- | SE<br>Note 3 |
| Irradiance<br>source | LED | -- | LED | SE<br>Note 3 |
| Visible light<br>LEDs | Yes | Yes | Yes | SE |
| Compliance<br>with 21 CFR<br>898 | Yes | Yes | Yes | SE |
| EMC | IEC 60601-1-2 | EN 60601-1-2 | IEC 60601-2 | SE |
| Safety | IEC 60601-1, IEC<br>60601-2-10 and IEC<br>60601-2-57 | IEC 60601-1, IEC<br>60601-2-10 and<br>IEC 60601-2-57 | IEC 60601-1 and<br>IEC 60601-2-57 | SE |

## Comparison in Detail(s):

## Note 1

We find that the combined the predicate devices NuFace® Plus (K103472), LED Phototherapy (PL-120) (K162098) can be equivalent to the subject device per the predicates' 510(k) summary. So the differences will not raise any safety or effectiveness issue.

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## Note 2

Although the Main Unit Weight, Dimensions of device, Housing Materials of main unit, Power source, Number of Output channels, Indicator and Time Range of subject device is different from the predicate devices, they are all compliance with IEC 60601-2-10 requirement for the product. So the differences of function specification will not raise any safety or effectiveness issue.

## Note 3

Although the Wavelengths, Energy emitted during the treatment, Irradiation area, Waveform and Shape, Maximum Output Voltage, Maximum Output Current, Maximum Phase Charge, Maximum Current Density, Maximum Power Density, Pulse Duration, Frequency and Irradiance source is a little different from the predicate devices, they are all compliance with IEC 60601-2-57 requirements. So the differences will not raise any safety or effectiveness issue.

## Note 4

Although the Irradiances is a little different from the predicate devices, but they are within the deviation range, so the differences will not raise any safety or effectiveness issue.

## Final Conclusion:

The subject device "2 Face / Face Evolution" is Substantial Equivalent to the predicate devices.