The device is intended for facial stimulation by electrode heads for cosmetic use. The device is also intended for the treatment of periorbital wrinkles with red Light Emitting Diode (LED) head. It is for over-the-counter use.

Device Description

The Device is equipped with three replaceable treatment heads; two treatment heads are electrode heads for micro current output to stimulate facial skin (Bigger one, and smaller one), the other treatment head is LED lamp holder.

For two micro current treatment heads of instrument, they can be exchanged for different skin part to use. The bigger one is for face tissue on cheeks and the smaller one is for facial tissue below eye region. It should be used about 10 minutes/2 to 3 times per week. The red is for red-light caring (about 3 minutes/2 to 3 times per week.)The product is supplied with an internal lithium rechargeable battery; It can be charged by 5V voltage of battery charger connected by standard USB cable. During battery charging, the LED lights start flash circling until charging is completed.

There are two kinds of electrode heads, one bigger electrode head is for cheek stimulation; and smaller electrode head is for stimulation on under eyes area. There are no electronic component inside of either heads. It is only for conduct stimulation current.

AI/ML Overview

This document is a 510(k) Pre-Market Notification for the "Micro-current Wrinkle Reduction Facial Service, Model EP-400". It details the device's technical specifications and compares it to predicate devices to establish substantial equivalence. However, it does not contain a study proving the device meets specific acceptance criteria in terms of clinical performance or effectiveness beyond safety and technical standards.

The document discusses tests for safety and technical performance, but not clinical efficacy in reducing wrinkles or providing facial stimulation results. The "Test Summary" section lists various engineering and safety standards used for evaluation, which are common for device clearance but do not address clinical outcomes.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria for clinical performance (e.g., wrinkle reduction percentage, subjective improvement scores) or reported device performance against such metrics. Instead, the acceptance is based on compliance with various engineering, safety, and compatibility standards.

Acceptance Criteria (Type)	Reported Device Performance (Compliance)
Electrical safety (IEC 60601-1, IEC 60601-2-10)	Compliant
Electromagnetic compatibility (IEC 60601-1-2)	Compliant
Photobiological safety (IEC 62471)	Compliant
Software verification and validation (FDA Guidance)	Compliant
Waveform output specifications (IEC 60601-2-10, Guidance for Powered Muscle Stimulator)	Compliant (waveform test report to verify output specifications)
Biocompatibility (ISO 10993-5, ISO 10993-10)	Compliant

2. Sample size used for the test set and the data provenance

The document describes bench testing for engineering and safety standards, not a clinical test set with human subjects. Therefore, the concept of "sample size used for the test set" and "data provenance" (country of origin, retrospective/prospective) in a clinical context is not applicable here. The testing was performed on the device itself in a lab setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable as there is no clinical test set with a "ground truth" established by human experts for clinical outcomes. The "ground truth" for the engineering and safety tests would be the specifications outlined in the respective standards, verified by testing specialists in a lab.

4. Adjudication method for the test set

Not applicable as there is no clinical test set requiring adjudication of findings.

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

Not applicable. This device is a physical therapy/cosmetic device, not an AI-powered diagnostic or assistive technology for human readers/clinicians, and no MRMC study is mentioned.

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

This question is geared towards AI/software performance. The document describes a physical medical device. While it mentions "Software verification and validation test" according to FDA guidance, this refers to the internal software controlling the device's functions, not an AI algorithm performing a standalone clinical task. Therefore, "standalone (algorithm only without human-in-the-loop performance)" is not applicable in the context of clinical efficacy for this device.

7. The type of ground truth used

For the safety and performance tests conducted, the "ground truth" would be the technical specifications, requirements, and acceptable ranges defined by the cited IEC and ISO standards (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2, IEC 62471, ISO 10993-5, ISO 10993-10, and FDA Guidance for Pre Market Submissions and for Software Contained in Medical Devices, Guidance for Powered Muscle Stimulator).

8. The sample size for the training set

Not applicable. This is not a machine learning or AI algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for an AI algorithm.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles a stylized human figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 3, 2017

Li-Tek Electronic Technology Corporation % Jet Li Regulation manager Guangzhou LETA Testing Technology Co., Ltd 6F, No.1 TianTai Road, Science City, LuoGang District Guangzhou, CN Guangdong

Re: K162106

Trade/Device Name: Micro-current Wrinkle Reduction Facial Service, Model EP-400 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NFO Dated: December 31, 2016 Received: January 9, 2017

Dear Jet Li:

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 801); medical device reporting (reporting of medical device

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Michael J. Hoffmann -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) K162106

Device Name

Micro-current Wrinkle Reduction Facial service, Model EP-400

Indications for Use (Describe)

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 K162106

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

510k preparation date: 2017-01-25

1. Submitter's Information

510(k) Owner's Name: Li-Tek Electronics Technologies Establishment Registration Number: Address: No.8~13,the industrial park of Jinshagang Shixia village, Dalangtown, Dongguan city, Guangdong, China

Phone: 0769-83117755 Fax: 0769-83117759 Contact Person: Barry Yuan (Quality Director) E-mail: quality5@li-tek.com

Application Correspondent:

Company: Guangzhou LETA Testing Technology Co., Ltd. Address: 6F, No.1 TianTai road Science City, LuoGang District, GuangZhou City, China Contact Person: Mr. Jet Li Tile: Regulation Manager Tel: +86-20-22325619 Email: med-jl@foxmail.com

2. Subject Device Information

Type of 510(k) submission: Traditional Common Name: Laser surqical instrument for use in general and plastic surgery and in dermatology, Transcutaneous electrical nerve stimulator for pain relief.

Trade Name: Micro-current Wrinkle Reduction Facial service, model EP-400

Classification Name: Light Based Over The Counter Wrinkle Reduction; Stimulator,

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Transcutaneous Electrical, Aesthetic Purposes Review Panel: General & Plastic Surgery, Neurology

Product Code: OHS, NFO

Requlation Number: 878.4810, 882.5890

Regulation Class: 2

3. Predicate Device Information

Sponsor	BiosonicTechnologies,LIC.	EVERYWAYMEDICALINSTRUMENTCO., LTD.	Carol ColeCompany	Nutra Luxe MD,LLC
DeviceName	Beautiful ImageModel 900 FacialToning Device	MT-200 FacialMENS	NOFACE® Plus	Nutra Light Red
510(k)Number	K130045	K142794	K103472	K141308
ProductCode	NFO	NFO	NFO	OHS
RegulationNumber	882.5890	882.5890	882.5890	878.4810
RegulationClass	2	2	2	2

4. Device Description

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5. Intended Use / Indications for Use

6. Test Summary

EP-400 has been evaluated the safety and performance by lab bench testing as following:

� Electrical safety test according to IEC 60601-1 and IEC 60601-2-10 standards
� Electromagnetic compatibility test according to IEC 60601-1-2 standard
� Photobiological safety of lamps and lamp systems according to IEC62471
� Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"
� Waveform test report to verify the output specifications of the device according to IEC 60601-2-10 and Guidance for Powered Muscle Stimulator.

7. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, materials, mode of operation, and intended use of EP-400 is substantially equivalent to the predicate devices quoted above. The differences between the subject device and predicate devices do not raise new issues of safety and effectiveness.

ElementsofComparison	SubjectDevice	Predicate Device	Predicate Device	Predicate Device	PredicateDevice	Remark
Basic Unit Characteristics
Device Nameand Model	Micro-currentWrinkleReductionFacial Service,model EP-400	BeautifulImageModel 900FacialToning Device	MT-200MENS	NOFACE® Plus	Nutra Light Red	--
510(K)Number	K162106	K130045	K142794	K103472	K141308	--
Product Code	NFO, OHS	NFO	NFO	NFO	OHS	--
RegulationNumber	882.5890878.4810	882.5890	882.5890	882.5890	878.4810	--
ElementsofComparison	SubjectDevice	Predicate Device	Predicate Device	Predicate Device	PredicateDevice	Remark

Intended Use	The device isintended forfacialstimulation byelectrodeheads forcosmetic use.The device isalso intendedfor thetreatment ofperiorbitalwrinkles withred LightEmitting Diode(LED) head. Itis for over-the-counter use.	BiosonicTechnologiesModel 900 FacialToning Device isintended for facialstimulation and isindicated forprescriptioncosmetic use. Theanatomical site forapplication of theModel 900 is theface.	TheEverywayFacialMENS,model: MT-200 isintended for facialstimulationandindicated for over-the-countercosmetic use.	TheNOFACE®Plus Facial ToningDevice is intendedforfacialstimulation and isindicated for over-the-countercosmetic use. (21CFR 801 SubpartC). The anatomicalsite for applicationof the NOFACE®Plus is the face.	The Nutra LightRed is a non-invasive LEDlight device isintended/indicated for over- the -counter use forthe treatment ofperiorbitalwrinkles, andrhytides.	SENote 1
Apply parts	For microcurrentstimulation:Face;For Red light:periorbital	Face	Face	Face	periorbital	SE
PowerSources	1200mAhlithium battery	One 6V battery	9-Volt battery	4 rechargeablebatteries	Internal NI-MHrechargeablebattery	SENote 1
Method of LineCurrentIsolation	Battery SupplyN/A	N/A	Type BF	N/A	N/A	SENote 1
For Micro current facial stimulation function
Number ofModes forMicro currentstimulation	1	1	3 (8Hz, 9Hz, 10Hz)	1	N/A	SENote 1
Number ofChannels forMicro currentstimulation	1	1	1	1	N/A	SE
Elements ofComparison	SubjectDevice	Predicate Device	Predicate Device	Predicate Device	Predicate Device	Remark
-Synchronousor Alternating	Alternating	N/A	Alternating	Alternating	N/A	SE Note 1
Regulated Currentor RegulatedVoltage	RegulatedVoltage	Both	0-3mA (load 4kΩ)	Regulated Voltage	N/A	SE Note 1
Software/Firmware/Microprocessor control	Yes	Yes	Yes	Yes	Yes	SE
AutomaticOverload Trip	Yes	Yes	Yes	Not required due tocircuit design	N/A	SE
Automatic No-load Trip	Yes.	Yes	Yes	Yes	N/A	SE
AutomaticShut Off	Yes.	Yes	Yes	Yes	N/A	SE
PatientOverrideControl	Yes	Yes	N/A	Yes	N/A	SE
On/OffStatus	Yes	Yes	Yes	Yes	N/A	SE
IndicatororDisplay	LowBattery	Yes	Yes	Yes	Yes	N/A	SE
	Voltage/CurrentLevel	Yes	Yes	Yes	Yes	N/A	SE
Timer Range	10 minutes	None	20, 40 minutes andContinuous	21 minutes	N/A	SE Note 1
HousingMaterials andConstruction	Console: ABSplastic	Thermoplastic	ABS	Thermo Plastic	medical gradebiocompatibilityplastics viainjection molding	SE Note 1
Output Specification
ElementsofComparison	SubjectDevice	Predicate Device	Predicate Device	Predicate Device	PredicateDevice	Remark
Waveform	Pulsed Biphasic	Biphasic	Biphasic	Pulsed Monoilhasic	N/A	SENote 2
Shape	Rectangular	Rectangular	Rectangular	Modulated Square	N/A	SENote 2
MaximumOutputVoltage(+/-10%)	1.23V @ 500Ω3.64V @ 2kΩ10.9V @ 10kΩ	0.347V @ 500Ω1.242V @ 2kΩ5.780V @ 10kΩ	1.78V @500Ω6.64V @2KΩ16.2V @10KΩ	137mV @ 500Ω769mV @ 2kΩ3.82V @ 10kΩ	N/A	SENote 2
MaximumCurrentDensity	2.46mA @500Ω1.82mA @ 2kΩ1.09mA @10kΩ	0.647mA @ 500Ω0.625mA@ 2kΩ0.584mA@ 10kΩ	3.56mA @500Ω3.32mA @2KΩ1.62mA @10KΩ	274μΑ @ 500Ω387μA @ 2kΩ382μΑ @ 10kΩ	N/A	SENote 2
Frequencyrange	59.3Hz	0.62 1 - 308.6Hz	8Hz, 9Hz, 10Hz	8.40 Hz	N/A	SENote 2
Pulsewidthrange	4ms	3.24-1610ms	N/A	119ms	N/A	SENote 2
Pulseduration	4ms	3.24-1610ms	~49-63ms	N/A	N/A	SENote 2
Net Charge	9.04μC@ 500Ω	0 uC @5000	N/A	N/A	N/A	SENote 2
MaximumPhaseCharge	16.4µC@ 500Ω	190µC@ 500Ω	157.12uC(8Hz/500Ω)	23.06µC@ 500Ω	N/A	SENote 2
MaximumCurrentDensity	Bigger electrodehead:0.044 mA/cm²@500ΩSmallerelectrode head:0.42 mA/cm²@500Ω	1.486mA/cm²@500Ω	0.26mA/cm²(8Hz/500Ω)	0.419mA/cm²@500Ω	N/A	SENote 2
MaximumPowerDensity	Biggerelectrode head0.014 mW/cm²@ 500ΩSmallerelectrode head0.139 mW/cm²@ 500Ω	366 µW/cm² @500Ω	1.33mW/cm²(8Hz/10kΩ)	3.22 µW/cm² @500Ω	- N/A	SENote 2
ON time	Constant	10-30s	Constant	Constant	N/A	SE
OFF time	None	1-6s	None	None	N/A	SE
Elements ofComparison	SubjectDevice	Predicate Device	Predicate Device	Predicate Device	PredicateDevice	Remark
Contraction andRelaxation time	Adjustable, due to different modes.	Adjustable, due to different modes.	--	--	N/A	SE
For LED red light irradiation function
LEDwavelength	650+/-5nm	--	--	--	650 +/- 5nm	SE
LED PowerDensity	80mW/cm²	--	--	--	80mW/cm²	SE
Additional Features
Environmentfor operating	Temperature: 5 ~ 40° C	+ 50 to 1040 F(+10 to +40° C)	--	--	--	SE
Environmentfor storage	Temperature: - 25 ~70° CHumidity: 10 ~90% RH	- 29 to + 1670 F (- 34 to +76° C)0 to 95% - non-condensing	--	--	--	SE
Biocompatibility	All user directly contacting materials are compliance with ISO10993-5, ISO10993-10 and IEC 62471:2006 requirements.	All user directly contacting materials are compliance with ISO10993-5 and ISO10993-10 requirements.	All user directly contacting materials are compliance with ISO10993-5 and ISO10993-10 requirements.	All user directly contacting materials are compliance with ISO10993-5 and ISO10993-10 requirements.	All user directly contacting materials are compliance with ISO10993-5 , ISO10993-10 and IEC 62471:2006 requirements.	SE
ElectricalSafety	Comply with IEC 60601-1 and IEC 60601-2-10	Comply with IEC 60601-1 and IEC 60601-2-10	Comply with IEC 60601-1 and IEC 60601-2-10	Comply with IEC 60601-1 and IEC 60601-2-10	Comply with IEC 60601-1 and IEC 60601-2-10	SE
EMC	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2	SE

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Comparison in Detail(s):

Note 1:

Although the Power Sources, Method of Line Current Isolation, Synchronous or Alternating, Regulated Current or Regulated Voltage, Timer Range, Console weight, Housing Materials and

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Construction are a little different from the predicate devices, they are all compliant with requirements of IEC 60601-1, IEC 60601-1-2 and Guidance for Powered Muscle Stimulator. So the differences of the function specifications do not raise any safety or effectiveness issue.

Note 2:

Although the Waveform. Shape, maximum output voltage, maximum current density, frequency range, pulse width range, pulse duration, net charge, maximum phase charge, maximum current density, maximum power density, on time, off time, contraction time of subject device are a little different from the predicate devices, they are all compliant with the requirements of IEC 60601-1, IEC 60601-2-10, and Guidance for Powered Muscle Stimulator. So the differences of function specification do not raise any safety or effectiveness issue.

Conclusion:

The subject device "Micro-current Wrinkle Reduction Facial Service, model EP-400" is Substantial Equivalence 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).