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

K162652 · Li-Tek Electronic Technology Corporation · NFO · Oct 25, 2017 · Neurology

Device Facts

• Record ID: K162652
• Device Name: Smart Photon Micro-current Device, Model: EP-300
• Applicant: Li-Tek Electronic Technology Corporation
• Product Code: NFO · Neurology
• Decision Date: Oct 25, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

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

Device Story

Handheld device (EP-300) for home aesthetic use; features micro-current stimulation, red light, and blue light modes. Micro-current mode uses two pairs of electrode contactors to deliver biphasic pulsed electrical stimulation to facial skin; requires conductive gel. Red light mode (630±10nm) and blue light mode (415±10nm) utilize LEDs for phototherapy. User selects modes via button; device includes 5 intensity levels for stimulation. Device operates on 3.7V rechargeable lithium battery. Safety features include automatic overload/no-load trip and automatic shut-off. User-operated; output parameters (voltage, current, frequency) are pre-set or adjustable within defined ranges. Benefits include facial toning, wrinkle reduction, and acne treatment.

Clinical Evidence

Bench testing only. Evaluated for electrical safety (IEC 60601-1, IEC 60601-2-10), electromagnetic compatibility (IEC 60601-1-2), photobiological safety (IEC 62471), and non-laser light source safety (IEC 60601-2-57). Waveform testing verified output specifications. Software verified and validated per FDA guidance.

Technological Characteristics

ABS plastic housing; 3.7V 800mAh rechargeable lithium battery. Micro-current: biphasic pulsed waveform, 5 intensity levels. Phototherapy: Red LED (630±10nm, 80 mW/cm2), Blue LED (415±10nm, 50 mW/cm2). Biocompatibility per ISO 10993-5 and ISO 10993-10. Connectivity: None. Software: Microprocessor-controlled with automatic safety trips.

Indications for Use

Indicated for over-the-counter aesthetic facial stimulation, treatment of periorbital wrinkles (red light), and treatment of mild to moderate acne (blue light).

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

• Beautiful Image Model 900 Facial Toning Device (K130065)
• MT-200 Facial MENS (K142794)
• Silkn Blue (K121435)
• Nutra Light Red (K141308)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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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: [phone]

Fax: [phone]

Contact Person: Barry Yuan (Quality Director)

E-mail: [e-mail]

# 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: [phone]

Email: [e-mail]

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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 | Biosonic<br>Technologies, LIC. | EVERYWAY<br>MEDICAL<br>INSTRUMENT CO.,<br>LTD. | Home Skinovations<br>Ltd. | Nutra Luxe MD,<br>LLC |
|----------------------|------------------------------------------------------|------------------------------------------------|---------------------------|-----------------------|
| Device<br>Name | Beautiful Image<br>Model 900 Facial<br>Toning Device | MT-200 Facial<br>MENS | Silkn Blue | Nutra Light Red |
| 510(k)<br>Number | K130065 | K142794 | K121435 | K141308 |
| Product<br>Code | NFO | NFO | OLP | OHS |
| Regulation<br>Number | 882.5890 | 882.5890 | 882.5890 | 878.4810 |
| Regulation<br>Class | 2 | 2 | 2 | 2 |

- 2. Device Description

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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.

#### 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.

| Elements<br>of<br>Comparison | Subject<br>Device | Predicate<br>Device | Predicate<br>Device | Predicate<br>Device | Predicate<br>Device | Re<br>mark | |
|-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|----|
| | Basic Unit Characteristics | | | | | | |
| Device<br>Name<br>and | Smart Photon<br>Micro-current | Beautiful<br>Image Model 900 | MT-200<br>Facial | Silkn Blue | Nutra Light Red | -- | |
| Elements<br>of<br>Comparison | Subject<br>Device | Predicate<br>Device | Predicate<br>Device | Predicate<br>Device | Predicate<br>Device | Remark | |
| Model | Device, Model:<br>EP-300 | Facial Toning<br>Device | MENS | | | | |
| 510 (K)<br>Number | Applying | K130065 | K142794 | K121<br>435 | K141308 | -- | |
| Product<br>Code | NFO,<br>OHS, OLP | NFO | NFO | OLP | OHS | -- | |
| Regulation<br>Number | 882.5890,<br>878.4810 | 882.5890 | 882.5890 | 878.4810 | 878.4810 | -- | |
| Intended<br>Use | For micro<br>current<br>stimulation<br>mode: The<br>device is<br>intended for<br>facial<br>stimulation<br>and is<br>indicated for<br>over-the-<br>counter<br>aesthetic use.<br>For red light<br>irradiation<br>mode: The red<br>light is<br>intended for<br>the treatment<br>of periorbital<br>wrinkles, | Biosonic<br>Technologies<br>Model 900 Facial<br>Toning Device is<br>intended for facial<br>stimulation and is<br>indicated for<br>prescription<br>aesthetic use. The<br>anatomical site for<br>application of the<br>Model 900 is the<br>face. | The<br>Everyway<br>Facial<br>MENS,<br>model: MT-200 is<br>intended for facial<br>stimulation<br>and<br>indicated for over-<br>the-counter<br>aesthetic use. | The Silkn Blue is<br>indicated as an over<br>the<br>counter<br>phototherapy device<br>for the treatment of<br>mild to moderate<br>acne | The Nutra Light Red<br>is a non-invasive<br>LED light device is<br>intended/indicated<br>for over- the -<br>counter use for the<br>treatment of<br>periorbital wrinkles,<br>and rhytides. | SE | |
| Elements<br>of<br>Comparison | Subject<br>Device | Predicate<br>Device | Predicate<br>Device | Predicate<br>Device | Predicate<br>Device | Remark | |
| | For blue light<br>irradiation<br>mode: The<br>blue light is for<br>the treatment<br>of mild to<br>moderate<br>acne. | | | | | | |
| Apply parts | Face | Face | Face | Face | Face | SE | |
| Power<br>Sources | 3.7V, 800mAh<br>rechargeable<br>lithium battery | One 6V battery | 9-Volt battery | batteries | 4<br>rechargeable<br>batteries | SE<br>Note 1 | |
| Method of Line<br>Current<br>Isolation | Battery Supply<br>N/A | N/A | Type BF | N/A | N/A | SE<br>Note 1 | |
| | For Micro current facial stimulation function | | | | | | |
| Number of<br>Modes for<br>Micro current<br>stimulation | 1 | 1 | 3 (8Hz, 9Hz, 10Hz) | N/A | N/A | SE | |
| Number of<br>Channels for<br>Micro current<br>stimulation | 1 | 1 | 1 | N/A | N/A | SE | |
| -Synchronous<br>or Alternating | Alternating | N/A | Alternating | -- | N/A | SE | |
| Regulated<br>Current<br>or<br>Regulated<br>Voltage | Regulated<br>Voltage | Both | 0-3mA (load 4kΩ) | Regulated Voltage | N/A | SE | |
| Software/Firm<br>ware/Micropro | Yes | Yes | Yes | Yes | Yes | SE | |
| Elements<br>of<br>Comparison | Subject<br>Device | Predicate<br>Device | Predicate<br>Device | Predicate<br>Device | Predicate<br>Device | Remark | |
| cessor control | | | | | | | |
| Automatic<br>Overload Trip | Yes | Yes | Yes | -- | N/A | SE | |
| Automatic No-<br>load Trip | Yes. | Yes | Yes | -- | N/A | SE | |
| Automatic<br>Shut Off | Yes. | Yes | Yes | -- | N/A | SE | |
| Patient<br>Override<br>Control | Yes | Yes | -- | -- | N/A | SE | |
| On/Of<br>f<br>Statu<br>s | Yes | Yes | Yes | -- | -- | SE | |
| Indica<br>tor<br>Displ<br>ay | Low<br>Batter<br>y | Yes | Yes | Yes | -- | -- | SE |
| | Volta<br>ge/Cu<br>rrent<br>Level | Yes | Yes | Yes | -- | -- | SE |
| | | | | | | | |
| Timer Range | Yes(<br>minutes) | 10<br>None | 20, 40 minutes and<br>Continuous | -- | -- | SE<br>Note 2 | |
| Console<br>weight | 125 g including<br>battery | 10lbs | 115 g including<br>battery | -- | -- | SE<br>Note 3 | |
| Housing<br>Materials and<br>Construction | Console: ABS<br>plastic | Thermoplastic | ABS | Stainless steels 17-<br>4H,<br>Rigid ABS | medical grade<br>biocompatibility<br>plastics via injection | SE | |
| Elements<br>of<br>Comparison | Subject<br>Device | Predicate<br>Device | Predicate<br>Device | Predicate<br>Device | Predicate<br>Device | 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 | |
| Maximum<br>Output<br>Voltage<br>(+/-<br>10%) | $1.49V @ 500\Omega$<br>$2.48V @ 2k\Omega$<br>$10.6V @ 10k\Omega$ | $0.347V @ 500\Omega$<br>$1.242V @ 2k\Omega$<br>$5.780V @ 10k\Omega$ | $1.78V @500\Omega$<br>$6.64V @2k\Omega$<br>$16.2V @10k\Omega$ | N/A | N/A | SE<br>Note 4 | |
| Maximum<br>output<br>Current | $2.98mA @ 500\Omega$<br>$1.24mA @ 2k\Omega$<br>$1.06mA @ 10k\Omega$ | $0.647mA @ 500\Omega$<br>$0.625mA@ 2k\Omega$<br>$0.584mA@ 10k\Omega$ | $3.56mA @500\Omega$<br>$3.32mA @2k\Omega$<br>$1.62mA @10k\Omega$ | N/A | N/A | SE<br>Note 4 | |
| Frequency<br>range | 60Hz | 0.62 1 - 308.6 | 8Hz, 9Hz, 10Hz | N/A | N/A | SE<br>Note 5 | |
| Pulse<br>width<br>range | 4ms | 3.24-1610 ms | -- | N/A | N/A | SE<br>Note 5 | |
| Pulse<br>duration | 4ms | 3.24-1610 ms | ~49-63mS | N/A | N/A | SE<br>Note 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 | |
| Elements<br>of<br>Comparison | Subject<br>Device | Predicate<br>Device | Predicate<br>Device | Predicate<br>Device | Predicate<br>Device | Re<br>mark | |
| Current<br>Density | 500Ω | 500Ω | (8Hz/500Ω) | | | Note 6 | |
| Maximum<br>Power<br>Density | 0.216mW/cm²@<br>500Ω | 0.366 mW/cm² @<br>500Ω | 1.33mW/cm2<br>(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 | |
| Contraction<br>and<br>Relaxation<br>time | Adjustable,<br>due<br>to<br>different<br>modes. | Adjustable, due to<br>different modes. | -- | N/A | N/A | SE | |
| For LED red light irradiation function | | | | | | | |
| LED<br>wavelength | Red-light:<br>630±10nm<br>Blue<br>light :415±10nm | -- | -- | 415±15nm | 650 +/- 5nm | SE | |
| LED<br>Power<br>Density | Red light:<br>80 W/cm2<br>Blue light:<br>50 W/cm² | -- | -- | 50 W/cm² | 80mW/cm² | SE | |
| Additional Features | | | | | | | |
| Environment | Temperature: 5 | + 50 to 104°<br>F | | | | SE | |
| Elements<br>of<br>Comparison | Subject<br>Device | Predicate<br>Device | Predicate<br>Device | Predicate<br>Device | Predicate<br>Device | Remark | |
| for operating | ~ 40° C<br>Relative<br>humidity: <93%<br>RH | (+10 to +40° C) | -- | -- | -- | | |
| Environment<br>for storage | Temperature: -<br>25° C ~ 50° C<br>Relative<br>humidity:<br>10~95% RH | - 29 to + 167° F (-<br>34 to +76° C)<br>0 to 95% - non-<br>condensing | -- | -- | -- | SE | |
| Biocompa<br>tibility | All user<br>directly<br>contacting<br>materials are<br>compliance with<br>ISO10993-<br>5 ,ISO 10993-10<br>and IEC<br>62471:2006<br>requirements. | All user directly<br>contacting<br>materials are<br>compliance with<br>ISO10993-5 and<br>ISO10993-10<br>requirements. | All user directly<br>contacting materials<br>are compliance with<br>ISO10993-5 and<br>ISO10993-10<br>requirements…