For micro current stimulation mode: The Smart Photon Micro-current Device is intended for facial stimulation and is indicated for over-the-counter aesthetic use.

For red light irradiation mode: The red light is intended for the treatment of periorbital wrinkles,

For blue light irradiation mode: The blue light is for the treatment of mild to moderate acne.

Device Description

There are Micro current electrodes, Red LEDs, Blue LEDs in the treatment head for their individual treatment function. The device is provided with three operating function modes: Micro current stimulation mode, Red light irradiation mode, Blue light irradiation mode. Three operation modes can be selected by the "Mode" button. These modes only can work separately.

For Micro current stimulation mode:

The device has two pairs of electrode contactors for facial stimulation by applying an electrical micro current to electrodes. The output waveform is formed of regulated Voltage of Biphasic pulse and provided with 5 levels of output intensity, which can be adjusted by user.

The device requires the use of conductive gel provided together with the device.

For LED phototherapy function:

The device also can provide specific photon spectrum by LED lamps for Red light irradiation mode and Blue light irradiation mode. There are Red LED lamps and Blue LED lamps assembled in the treatment head.

In Red light irradiation mode, the device utilizes Light Emitting Diodes to emit red light. The output is pre-tuned to one wavelength with a narrow spectral bandwidth. The output wavelength of red light is 630±10nm and its power density is 80 mW/cm2.

In Blue light irradiation mode, the device utilizes Light Emitting Diodes to emit blue light. The output is pre-tuned to one wavelength with a narrow spectral bandwidth. The output wavelength of blue light is 415 ±10 nm and its power density is about 50 mW/cm².

For the facial stimulation model, the recommend treatment session is 10 minutes/2 to 3 times per week.

For light irradiation of red light, the recommend treatment session is 3 minutes/ 2-3 times per week. And for blue light, the recommend treatment session is 4 minutes/ 2 times per week on each treatment area.

AI/ML Overview

The provided text is a 510(k) summary for the "Smart Photon Micro-current Device: EP-300". This document primarily focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and safety testing. It does not include acceptance criteria for clinical performance or details of a clinical study to prove the device meets such criteria.

The "Test Summary" section (page 6) lists the tests performed, which are primarily related to safety, electrical compatibility, and software validation, not clinical effectiveness. There is no information about clinical acceptance criteria for aesthetic outcomes (e.g., reduction in periorbital wrinkles, improvement in acne).

Here's an analysis of what information is provided regarding testing and comparison, structured to answer your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria for clinical performance or a table of reported device performance against such criteria. Instead, it compares the subject device's specifications to those of predicate devices and states that safety and performance were evaluated through various engineering and electrical tests. The implicit "acceptance criterion" is to demonstrate substantial equivalence to the predicate devices through technical similarities and compliance with international safety standards.

The table below summarizes the comparative technical specifications and the conclusion of "Substantial Equivalence (SE)" provided in the document. This is not a direct assessment of an "acceptance criterion" for clinical efficacy, but rather a comparison of technical features to establish equivalence for regulatory purposes.

Elements of Comparison (Acceptance Criteria are inferred technical specifications found in predicate devices or safety standards)	Subject Device Performance (Reported Performance)
Device Name and Model	Smart Photon Micro-current Device, Model: EP-300
Product Code	NFO, OHS, OLP
Regulation Number	882.5890, 878.4810
Intended Use (Micro-current mode)	Facial stimulation for over-the-counter aesthetic use.
Intended Use (Red light mode)	Treatment of periorbital wrinkles.
Intended Use (Blue light mode)	Treatment of mild to moderate acne.
Applicable Body Parts	Face
Power Sources	3.7V, 800mAh rechargeable lithium battery (Note 1: Safety/effectiveness comparable to predicate's different power sources)
Method of Line Current Isolation	Battery Supply N/A (Note 1: Safety/effectiveness comparable to predicate's different isolation methods)
Number of Modes for Micro current stimulation	1
Number of Channels for Micro current stimulation	1
Synchronous or Alternating	Alternating
Regulated Current or Regulated Voltage	Regulated Voltage
Software/Firmware/Microprocessor Control	Yes
Automatic Overload Trip	Yes
Automatic No-load Trip	Yes.
Automatic Shut Off	Yes.
Patient Override Control	Yes
On/Off Status Indicator	Yes
Indicator Display (Low Battery)	Yes
Indicator Display (Voltage/Current Level)	Yes
Timer Range	Yes (minutes), adjustable (Note 2: Differences in timer range do not affect safety/effectiveness based on intended use and user manual guidance)
Console weight	125 g including battery (Note 3: Minor weight differences comply with IEC60601-1 and do not affect safety/effectiveness)
Housing Materials and Construction	Console: ABS plastic
Micro current Output Waveform	Pulsed Biphasic, Rectangular shape
Maximum Output Voltage (+/- 10%)	1.49V @ 500Ω, 2.48V @ 2kΩ, 10.6V @ 10kΩ (Note 4: Within range of predicate devices; complies with safety standards)
Maximum Output Current	2.98mA @ 500Ω, 1.24mA @ 2kΩ, 1.06mA @ 10kΩ (Note 4: Within range of predicate devices; complies with safety standards)
Frequency range	60Hz (Note 5: Minor differences comparable to predicate and covered by K130065; complies with safety standards)
Pulse width range	4ms (Note 5: Minor differences comparable to predicate and covered by K130065; complies with safety standards)
Pulse duration	4ms (Note 5: Minor differences comparable to predicate and covered by K130065; complies with safety standards)
Net Charge	0 µC @ 500Ω
Maximum Current Density	0.524mA/cm² @ 500Ω (Note 6: Within range of predicate devices)
Maximum Power Density	0.216mW/cm² @ 500Ω (Note 6: Within range of predicate devices and meets FDA guidance max of 0.25 W/cm²)
ON time	Constant
OFF time	None
Contraction and Relaxation time	Adjustable, due to different modes.
Red LED wavelength	630±10nm (Note 7: Close to predicate; passed IEC62471 and IEC60601-2-57)
Blue LED wavelength	415±10nm (Note 7: Same as predicate; passed IEC62471 and IEC60601-2-57)
Red LED Power Density	80 W/cm2
Blue LED Power Density	50 W/cm²
Operating Environment (Temperature, Humidity)	5 ~ 40 °C, <93% RH
Storage Environment (Temperature, Humidity)	-25 ~ 50 °C, 10~95% RH
Biocompatibility	All user directly contacting materials comply with ISO10993-5, ISO 10993-10, and IEC 62471:2006 requirements.
Electrical Safety	Comply with IEC 60601-1 and IEC 60601-2-10
EMC	Comply with IEC 60601-1-2

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document lists various engineering and performance bench tests (e.g., electrical safety, EMC, software verification, waveform tests, photobiological safety). These are not clinical studies involving human subjects or test sets of data from clinical populations in the way you might expect for an AI diagnostic device. Therefore, the concept of a "sample size for the test set" or "data provenance" (country of origin, retrospective/prospective) related to clinical performance is not applicable here.

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

Not applicable. This device's submission revolves around demonstrating substantial equivalence through technical specifications and safety standards, not through clinical expert evaluation of its efficacy in reducing wrinkles or treating acne.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as there is no clinical test set requiring expert adjudication for establishing ground truth of clinical outcomes.

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 is not an AI diagnostic device, nor is any clinical comparative effectiveness study involving human readers or AI assistance described.

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

Not applicable. This device is not an algorithm, but a physical electronic device. Its performance is measured directly by adherence to specified electrical and optical parameters and safety standards, not as a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the technical performance aspects, the "ground truth" is defined by the technical specifications outlined in international standards (e.g., IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2, IEC 62471, IEC 60601-2-57) and the technical parameters of the predicate devices. For biocompatibility, the ground truth is compliance with ISO 10993-5 and ISO 10993-10. There is no mention of clinical "ground truth" (e.g., confirmed pathology for acne, dermatologist assessment of wrinkle reduction) as the submission relies on substantial equivalence for indications.

8. The sample size for the training set

Not applicable. This is not a machine learning device and therefore does not involve a training set.

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

Not applicable, as there is no training set.

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 consists of a stylized depiction of three human profiles facing right, arranged in a stacked formation. The profiles are rendered in a dark color, creating a silhouette effect. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the profile graphic.

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

October 25, 2017

Li-tek Electronic Technology Corporation % Mr. Jet Li Regulation Manager Guangzhou Leta Testing Technology Co., Ltd 6f, No.1 Tiantai Road, Science City, Luogang District Guangzhou, China

Re: K162652

Trade/Device Name: Smart Photon Micro-current Device: EP-300 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: September 14, 2017 Received: September 19, 2017

Dear Mr. 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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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, Jennifer R. Stevenson -

S3 For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K162652

Device Name

Smart Photon Micro-current Device, Model: EP-300

Indications for Use (Describe)

For micro current stimulation mode: The Smart Photon Micro-current Device is intended for facial stimulation and is indicated for over-the-counter aesthetic use.

For red light irradiation mode: The red light is intended for the treatment of periorbital wrinkles,

For blue light irradiation mode: The blue light is for the treatment of mild to moderate acne.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

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Chapter 6.510(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.

1. Date of the summary prepared: October 25, 2017

There is no prior submission for the device.

2. Submitter's Information

510(k) Owner's Name: Li-Tek Electronic Technology Corporation

Establishment Registration Number:

Address: No.8~13, the industrial park of Jinshagang, Shixiavillage, Dalangtown, Dongguancity, 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, GuangZhouCity, China

Contact Person: Mr. Jet Li

Tile: Regulation Manager

Tel: +86-20-22325619

Email: med-jl@foxmail.com

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3. Subject Device Information

Type of 510(k) submission: Traditional

Common Name: Light based over the counter wrinkle reduction; over-the-counter powered light based laser for acne; stimulator, transcutaneous electrical, aesthetic purposes.

Trade Name: Smart Photon Micro-current Device, Model: EP-300

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

Transcutaneous Electrical, Aesthetic Purposes; Over-the-counter powered light based laser for acne.

Review Panel: General & Plastic Surgery, Neurology

Product Code: OHS, NFO, OLP

Regulation Number: 878.4810, 882.5890

Regulation Class: 2

4. Predicate Device Information

Sponsor	BiosonicTechnologies, LIC.	EVERYWAYMEDICALINSTRUMENT CO.,LTD.	Home SkinovationsLtd.	Nutra Luxe MD,LLC
DeviceName	Beautiful ImageModel 900 FacialToning Device	MT-200 FacialMENS	Silkn Blue	Nutra Light Red
510(k)Number	K130065	K142794	K121435	K141308
ProductCode	NFO	NFO	OLP	OHS
RegulationNumber	882.5890	882.5890	882.5890	878.4810
RegulationClass	2	2	2	2

1. Device Description

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For Micro current stimulation mode:

The device requires the use of conductive gel provided together with the device.

For LED phototherapy function:

For the facial stimulation model, the recommend treatment session is 10 minutes/2 to 3 times per week.

5. Intended Use / Indications for Use

For micro current stimulation mode: The Smart Photon Micro-current Device is intended for facial stimulation and is indicated for over-the-counter aesthetic use.

For red light irradiation mode: The red light is intended for the treatment of periorbital wrinkles,

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For blue light irradiation mode: The blue light is for the treatment of mild to moderate acne.

6. Test Summary

EP-300 has been evaluated the safety and performance by lab bench testing as following:

� Electrical safety test according to IEC 60601-1:2005 +A1:2012 and IEC 60601-2-10: 2012 standards
� Electromagnetic compatibility test according to standard IEC 60601-1-2: 2014
� Photo biological safety of LED lamp systems according to IEC62471:2006
◆ 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 60601-2-10:2012 and Guidance for Powered Muscle Stimulator.
◆ Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use according to IEC60601-2-57:2011

7. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, materials, mode of operation, and intended use of EP-300 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 or effectiveness.

ElementsofComparison	SubjectDevice	PredicateDevice	PredicateDevice	PredicateDevice	PredicateDevice	Remark
	Basic Unit Characteristics
DeviceNameand	Smart PhotonMicro-current	BeautifulImage Model 900	MT-200Facial	Silkn Blue	Nutra Light Red	--
ElementsofComparison	SubjectDevice	PredicateDevice	PredicateDevice	PredicateDevice	PredicateDevice	Remark
Model	Device, Model:EP-300	Facial ToningDevice	MENS
510 (K)Number	Applying	K130065	K142794	K121435	K141308	--
ProductCode	NFO,OHS, OLP	NFO	NFO	OLP	OHS	--
RegulationNumber	882.5890,878.4810	882.5890	882.5890	878.4810	878.4810	--
IntendedUse	For microcurrentstimulationmode: Thedevice isintended forfacialstimulationand isindicated forover-the-counteraesthetic use.For red lightirradiationmode: The redlight isintended forthe treatmentof periorbitalwrinkles,	BiosonicTechnologiesModel 900 FacialToning Device isintended for facialstimulation and isindicated forprescriptionaesthetic use. Theanatomical site forapplication of theModel 900 is theface.	TheEverywayFacialMENS,model: MT-200 isintended for facialstimulationandindicated for over-the-counteraesthetic use.	The Silkn Blue isindicated as an overthecounterphototherapy devicefor the treatment ofmild to moderateacne	The Nutra Light Redis a non-invasiveLED light device isintended/indicatedfor over- the -counter use for thetreatment ofperiorbital wrinkles,and rhytides.	SE
ElementsofComparison	SubjectDevice	PredicateDevice	PredicateDevice	PredicateDevice	PredicateDevice	Remark
	For blue lightirradiationmode: Theblue light is forthe treatmentof mild tomoderateacne.
Apply parts	Face	Face	Face	Face	Face	SE
PowerSources	3.7V, 800mAhrechargeablelithium battery	One 6V battery	9-Volt battery	batteries	4rechargeablebatteries	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)	N/A	N/A	SE
Number ofChannels forMicro currentstimulation	1	1	1	N/A	N/A	SE
-Synchronousor Alternating	Alternating	N/A	Alternating	--	N/A	SE
RegulatedCurrentorRegulatedVoltage	RegulatedVoltage	Both	0-3mA (load 4kΩ)	Regulated Voltage	N/A	SE
Software/Firmware/Micropro	Yes	Yes	Yes	Yes	Yes	SE
ElementsofComparison	SubjectDevice	PredicateDevice	PredicateDevice	PredicateDevice	PredicateDevice	Remark
cessor control
AutomaticOverload Trip	Yes	Yes	Yes	--	N/A	SE
Automatic No-load Trip	Yes.	Yes	Yes	--	N/A	SE
AutomaticShut Off	Yes.	Yes	Yes	--	N/A	SE
PatientOverrideControl	Yes	Yes	--	--	N/A	SE
On/OffStatus	Yes	Yes	Yes	--	--	SE
IndicatorDisplay	LowBattery	Yes	Yes	Yes	--	--	SE
	Voltage/CurrentLevel	Yes	Yes	Yes	--	--	SE

Timer Range	Yes(minutes)	10None	20, 40 minutes andContinuous	--	--	SENote 2
Consoleweight	125 g includingbattery	10lbs	115 g includingbattery	--	--	SENote 3
HousingMaterials andConstruction	Console: ABSplastic	Thermoplastic	ABS	Stainless steels 17-4H,Rigid ABS	medical gradebiocompatibilityplastics via injection	SE
ElementsofComparison	SubjectDevice	PredicateDevice	PredicateDevice	PredicateDevice	PredicateDevice	Remark
					molding
	Micro current Output Specification
Waveform	Pulsed Biphasic	Biphasic	Biphasic	N/A	N/A	SE
Shape	Rectangular	Rectangular	Rectangular	N/A	N/A	SE
MaximumOutputVoltage(+/-10%)	$1.49V @ 500\Omega$$2.48V @ 2k\Omega$$10.6V @ 10k\Omega$	$0.347V @ 500\Omega$$1.242V @ 2k\Omega$$5.780V @ 10k\Omega$	$1.78V @500\Omega$$6.64V @2k\Omega$$16.2V @10k\Omega$	N/A	N/A	SENote 4
MaximumoutputCurrent	$2.98mA @ 500\Omega$$1.24mA @ 2k\Omega$$1.06mA @ 10k\Omega$	$0.647mA @ 500\Omega$$0.625mA@ 2k\Omega$$0.584mA@ 10k\Omega$	$3.56mA @500\Omega$$3.32mA @2k\Omega$$1.62mA @10k\Omega$	N/A	N/A	SENote 4
Frequencyrange	60Hz	0.62 1 - 308.6	8Hz, 9Hz, 10Hz	N/A	N/A	SENote 5
Pulsewidthrange	4ms	3.24-1610 ms	--	N/A	N/A	SENote 5
Pulseduration	4ms	3.24-1610 ms	~49-63mS	N/A	N/A	SENote 5
Net Charge	$0 \mu C @ 500\Omega$	$0 uC @500\Omega$	19.64 uC	N/A	N/A	SE
Maximum	0.524mA/cm²@	1.486mA/cm²@	0.26mA/cm2	N/A	N/A	SE
ElementsofComparison	SubjectDevice	PredicateDevice	PredicateDevice	PredicateDevice	PredicateDevice	Remark
CurrentDensity	500Ω	500Ω	(8Hz/500Ω)			Note 6
MaximumPowerDensity	0.216mW/cm²@500Ω	0.366 mW/cm² @500Ω	1.33mW/cm2(8Hz/10kΩ)	N/A	N/A	SE
ON time	Constant	10-30s	Constant	N/A	N/A	SE
OFF time	None	1-6s	None	N/A	N/A	SE
ContractionandRelaxationtime	Adjustable,duetodifferentmodes.	Adjustable, due todifferent modes.	--	N/A	N/A	SE
For LED red light irradiation function
LEDwavelength	Red-light:630±10nmBluelight :415±10nm	--	--	415±15nm	650 +/- 5nm	SE
LEDPowerDensity	Red light:80 W/cm2Blue light:50 W/cm²	--	--	50 W/cm²	80mW/cm²	SE
Additional Features
Environment	Temperature: 5	+ 50 to 104°F				SE
ElementsofComparison	SubjectDevice	PredicateDevice	PredicateDevice	PredicateDevice	PredicateDevice	Remark
for operating	~ 40° CRelativehumidity: <93%RH	(+10 to +40° C)	--	--	--
Environmentfor storage	Temperature: -25° C ~ 50° CRelativehumidity:10~95% RH	- 29 to + 167° F (-34 to +76° C)0 to 95% - non-condensing	--	--	--	SE
Biocompatibility	All userdirectlycontactingmaterials arecompliance withISO10993-5 ,ISO 10993-10and IEC62471:2006requirements.	All user directlycontactingmaterials arecompliance withISO10993-5 andISO10993-10requirements.	All user directlycontacting materialsare compliance withISO10993-5 andISO10993-10requirements	All user directlycontacting materialsare compliance withISO10993-5andISO10993-10requirements.	All user directlycontacting materialsare compliance withISO10993-5,ISO10993-10 andIEC62471:2006requirements.	SE
ElectricalSafety	Comply withIEC60601-1and IEC 60601-2-10	Comply withIEC 60601-1 andIEC 60601-2-10	Comply withIEC 60601-1 andIEC 60601-2-10	Comply withIEC 60601-1	Comply withIEC 60601-1	SE
EMC	Comply withIEC 60601-1-2	Comply withIEC 60601-1-2	Comply withIEC 60601-1-2	Comply withIEC 60601-1-2	Comply withIEC 60601-1-2	SE

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Comparison in Detail(s):

Note 1 (Power Source(s) and Method of Line Current Isolation):

The design of the power source is according to the circuit design of the device, which should ensure the safety and effectiveness. Our product complies with IEC 60601-1 requirements, so the difference on Power source and method of line current isolation would not introduce electric

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safety impact. Also, the performance of our device is substantially equivalent to the predicate devices under this power supply condition, which would be discussed in the follow description.

Note 2 (Timer Range):

The design of the timer range is basing on the intended use. As the subject device has three functions, including Red LED light therapy, Blue LED light therapy and Micro current stimulation, therefore the user could adjust the time by the modes based on user instruction. And the user will adjust the time as recommended treatment time for expected result according to the user manual. So the difference of timer range would not affect the safety and effectiveness of subject device.

Note 3 (Weight):

Even the weight of device is different to the predicate device, but all of them belong to handled device, and it complied with IEC60601-1 Testing. So the minor difference on weight and dimensions won't affect the safety and effectiveness of the device so it can deemed as the substantially equivalence.

Note 4 (Maximum Output Voltage and Maximum Output Current):

The effect of micro current stimulation are determined by micro current output waveform and output current. There is minor difference on the maximum output voltage and current between the subject device and the predicate devices, however the value of output voltage and output current are in the range which is between the value of K130065 and K142794. Also, the subject device complies with IEC 60601-1 and IEC60601-2-10 for safety and performance evaluation. Therefore, the difference on maximum output voltage and output current would not affect the safety and effectiveness of subject device.

Note 5 (Frequency and Pulse duration):

The effect of micro current stimulation are determined by micro current output waveform and output current. Frequency and pulse duration is the time parameter of the waveform. There is only little difference on the Frequency and pulse duration between the subject device and the predicate devices, it can still obtain the same effect because our output voltage and output current is in the range which is between the value of K130065 and K142794, and the Frequency,

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Pulse duration was cover by K130065. Also, the subject device complies with IEC 60601-1 and IEC60601-2-10 for safety and performance evaluation. Therefore, the difference on Frequency and Pulse duration would not affect the safety and effectiveness of subject device.

Note 6 (Maximum current density and Maximum power density):

The effect of micro current stimulation on facial skin are determined by micro current output waveform and output current. There is minor difference on the maximum current density and maximum power density between the subject device and the predicate devices, but the value of current density and maximum power density of subject device are in the range which is between the value of K130065 and K142794. And the maximum power density meet with the maximum allowed value 0.25 (W/cm²) required in FDA guidance. Therefore, the subject device and predicate devices are substantially equivalence on these parameters.

Note 7 (LED Wavelengths):

The wavelength of blue light of subject device is same to predicate device and the red light is very close to the predicate device. The difference of the red light wavelength is minor between the subject device and the predicate devices; and the subject device has passed the testing according to IEC62471 and IEC60601-2-57 for safety and performance evaluation. Therefore, we thought that such difference on the wavelengths of LED light would not affect the safety and effectiveness of subject device.

Finial Conclusion:

The subject device Smart Photon Micro-current Device, Model: EP-300 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).