(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 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.

AI/ML Overview

This document is a 510(k) summary for the medical device "2 Face / Face Evolution" by Heat In A Click. It asserts substantial equivalence to predicate devices based on safety and performance evaluations.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria or performance metrics in a typical sense for an AI-powered device. Instead, it demonstrates compliance with various medical device standards and provides a comparison table against two predicate devices. The "performance" in this context refers to the device's adherence to safety and electromagnetic compatibility standards, as well as its physical and electrical specifications matching or being within acceptable ranges compared to the predicates.

The closest we can get to a table for an AI device would be:

Feature/Metric (if AI were present)	Acceptance Criteria (Implied: Compliance with relevant standards and ranges of predicate devices)	Reported Device Performance (as compared to predicates)
Biocompatibility	AAMI/ANSI/ISO 10993-5:2009(R) 2014 (in vitro cytotoxicity), ISO 10993-10:2010-08-01 (irritation and skin sensitization)	Compliant
Electromagnetic Compatibility (EMC)	IEC/EN 60601-1-2: 2014-02	Compliant
Basic Safety & Essential Performance (Home Healthcare)	IEC 60601-1-11:2010	Compliant
Basic Safety & Essential Performance (Non-laser Light Source)	IEC 60601-2-57:2011	Compliant (Wavelengths, Energy emitted, Irradiation area, Irradiances within deviation range, LED power, etc., are compared and found to be compliant with requirements, see table sections on Waveform and Shape, Wavelengths, Energy emitted, etc.)
Usability	IEC 60601-1-6: 2010 (Third Edition), IEC 62366:2007 + A1:2014	Compliant
Basic Safety & Essential Performance (Nerve & Muscle Stimulators)	IEC 60601-2-10: 2012 (Second Edition)	Compliant (e.g., Output Voltage, Current, Phase Charge, Current Density, Power Density, Pulse Duration, Frequency are compared and found to be compliant with requirements)
Battery Safety	IEC 62133 Edition 2.0 2012-12	Compliant
Software Life-Cycle Processes	IEC 62304: 2006 (First Edition)	Compliant
Compliance with 21 CFR 898	Yes	Yes

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

This document primarily describes a device for aesthetic purposes (facial stimulation, periorbital wrinkles, mild to moderate inflammatory acne) and focuses on engineering and safety testing. It does not mention a "test set" in the context of an AI algorithm or data-driven performance evaluation. The testing conducted is laboratory bench testing against established medical device standards. Therefore, there is no sample size or data provenance related to a test set of patient data.

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

This information is not applicable as the document does not describe a study involving a "test set" requiring ground truth established by experts for an AI algorithm. The evaluations are against technical standards and comparisons to predicate devices.

4. Adjudication Method for the Test Set

This information is not applicable as there is no "test set" requiring an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable. The device described is a physical hand-held aesthetic device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, no MRMC study or AI-related effect size data is presented.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The device is an electro-mechanical and light-emitting device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established performance and safety requirements outlined in the various international medical device standards (e.g., ISO, IEC) and the comparative specifications of the legally marketed predicate devices. The device's performance is measured against these technical standards and predicate device characteristics, not against clinical outcomes or expert consensus on patient data.

8. The Sample Size for the Training Set

This information is not applicable as the document does not describe an AI algorithm that requires a training set.

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

This information is not applicable as there is no AI algorithm training set.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)	Over-The-Counter Use (21 CFR 801 Subpart C)
-------------------------------------------------	-----------------------------------------------------------------

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

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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: 1(954)518-9777 Fax No.: 1(954)320-7984 Contact Person (including title): Guy Levi (CEO) E-mail: hagar@palmmassager.com

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: +86-20-61099984 Email: regulatory@glomed-info.com

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 ElectronicsTechnologies
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

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 ofComparison	Subject Device	Predicate Device	Remark		NiMH batteries	Li battery	Note 2
Manufacturer	Heat In A Click	Carol ColeCompany	--	Average DC current through electrodes when device is on but no pulses are being applied	0A	0A	--	SE
Device Nameand Model	2 Face / FaceEvolution	NuFace® Plus	--	Number of Output channels	2	1	--	SENote 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 forUse	2 Face / FaceEvolution is a hand-held device for over-the counter aestheticpurposes.(1) The EMS mode isindicated for facialstimulation;(2) The Photon mode:The red light isintended for thetreatment of periorbitalwrinkles and the bluelight is intended for thetreatment of the mild tomoderate inflammatoryacne.	The NuFace® PlusFacial ToningDevice is intendedfor facialstimulation and isindicated for over-the-countercosmetic use.	SENote 1	Automatic Overload Trip?	No	No	Yes	SE
AnatomicalSites	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
TargetPopulation	Individuals withperiorbital wrinkles,Individuals with mildto moderateinflammatory acne	Individuals seekingfacial simulation foraesthetic 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.	--	SENote 2
Environment ofUse	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	SENote 2
Method of LinecurrentIsolation	Type BF	Type BF	SE	Wavelengths	Red Light (630nm±3nm Wavelength), Blue Light (415nm±3nm Wavelength)	--	Blue light:415nm±3nmRed light:630nm±3nm	SENote 3
Main UnitWeight	200g	9oz withoutcharging base	SENote 2	LED power	0.1 W	--	0.1 W	SE
Dimensions ofdevice (inch)[Wx LxD]	158mm56mm51.5mm	3"x 5.25"x 1.25"	SENote 2	Energy emitted during the treatment	1050J	--	1080J	SENote 3
HousingMaterials ofmain unit	ABS Plastic &Stainless Steel	Thermo Plastic	SENote 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%	SENote 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: 73.26mW/cm²±10%Blue light: 64.10mW/cm²±10%	--	Red light: 80mW/cm² ±10%Blue light: 65mW/cm²±10%	SENote 4
Waveform andShape	Pulsed Biphasic,Modulated Square	PulsedMonoPhasic,Modulated Square	--	SENote 3
MaximumOutput Voltage(+/- 10%)	310mV @ 500Ω1.16V @ 2KΩ5.56V @ 10KΩ	137 mV @ 500Ω769 mV @ 2 ΚΩ3.82 V @ 10 kΩ	--	SENote 3
MaximumOutput Current(+/- 10%)	620µA @ 500Ω580μΑ @ 2KΩ556μΑ @ 10KΩ	274μA @ 500Ω387μΑ @ 2KΩ283μΑ @ 10kΩ	--	SENote 3
MaximumPhase Charge	26.31μC @ 500Ω	23.06μC @ 500Ω	--	SENote 3
MaximumCurrent Density	0.330mA/cm² @500Ω(The MinimumElectrode Size:2.91cm²)	0.419mA/cm²@500Ω	--	SENote 3
MaximumPower Density	4.34μW/cm² @500Ω(The MinimumElectrode Size:2.91cm²)	3.22µW/cm²@500Ω	--	SENote 3
Pulse Duration	60ms	119ms	--	SENote 3
Frequency	8.333Hz	8.4Hz	--	SENote 3
Irradiancesource	LED	--	LED	SENote 3
Visible lightLEDs	Yes	Yes	Yes	SE
Compliancewith 21 CFR898	Yes	Yes	Yes	SE
EMC	IEC 60601-1-2	EN 60601-1-2	IEC 60601-2	SE
Safety	IEC 60601-1, IEC60601-2-10 and IEC60601-2-57	IEC 60601-1, IEC60601-2-10 andIEC 60601-2-57	IEC 60601-1 andIEC 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.

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
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.(b)
Classification. Class II (performance standards).