Micro-current Wrinkle Reduction Facial service, model EP-400
Device Facts
| Record ID | K162106 |
|---|---|
| Device Name | Micro-current Wrinkle Reduction Facial service, model EP-400 |
| Applicant | Li-Tek Electronic Technology Corporation |
| Product Code | NFO · Neurology |
| Decision Date | Feb 3, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.5890 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
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 Story
Device (Model EP-400) provides facial stimulation via two interchangeable electrode heads and periorbital wrinkle treatment via a red LED head. Operated by consumer (OTC); device uses internal rechargeable lithium battery. Micro-current stimulation delivered to cheeks or under-eye area; red light therapy applied to periorbital region. Device includes microprocessor control for output regulation, automatic overload/no-load trips, and automatic shut-off. User monitors status via LED indicators. Benefits include cosmetic facial toning and wrinkle reduction.
Clinical Evidence
Bench testing only. Evaluated electrical safety (IEC 60601-1, IEC 60601-2-10), electromagnetic compatibility (IEC 60601-1-2), photobiological safety (IEC 62471), software verification/validation, and waveform output specifications.
Technological Characteristics
Console: ABS plastic. Power: 1200mAh internal lithium rechargeable battery. Output: Pulsed biphasic waveform (micro-current) and 650nm (+/- 5nm) red LED light. Connectivity: USB charging. Software: Microprocessor-controlled with automatic shut-off and overload protection. Biocompatibility: ISO 10993-5, ISO 10993-10 compliant.
Indications for Use
Indicated for facial stimulation for cosmetic use and treatment of periorbital wrinkles in over-the-counter users.
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 (K130045)
- MT-200 Facial MENS (K142794)
- NOFACE® Plus (K103472)
- 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 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)
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.
| 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 | Biosonic<br>Technologies,<br>LIC. | EVERYWAY<br>MEDICAL<br>INSTRUMENT<br>CO., LTD. | Carol Cole<br>Company | Nutra Luxe MD,<br>LLC |
|----------------------|------------------------------------------------------|------------------------------------------------|-----------------------|-----------------------|
| Device<br>Name | Beautiful Image<br>Model 900 Facial<br>Toning Device | MT-200 Facial<br>MENS | NOFACE® Plus | Nutra Light Red |
| 510(k)<br>Number | K130045 | K142794 | K103472 | K141308 |
| Product<br>Code | NFO | NFO | NFO | OHS |
| Regulation<br>Number | 882.5890 | 882.5890 | 882.5890 | 878.4810 |
| Regulation<br>Class | 2 | 2 | 2 | 2 |
#### 4. 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.
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.
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.
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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.
## 5. Intended Use / Indications for Use
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.
## 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.
| Elements<br>of<br>Comparison | Subject<br>Device | Predicate Device | Predicate Device | Predicate Device | Predicate<br>Device | Remark | |
|-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|----|
| Basic Unit Characteristics | | | | | | | |
| Device Name<br>and Model | Micro-current<br>Wrinkle<br>Reduction<br>Facial Service,<br>model EP-400 | Beautiful<br>Image<br>Model 900<br>Facial<br>Toning Device | MT-200<br>MENS | NOFACE® Plus | Nutra Light Red | -- | |
| 510<br>(K)<br>Number | K162106 | K130045 | K142794 | K103472 | K141308 | -- | |
| Product Code | NFO, OHS | NFO | NFO | NFO | OHS | -- | |
| Regulation<br>Number | 882.5890<br>878.4810 | 882.5890 | 882.5890 | 882.5890 | 878.4810 | -- | |
| Elements<br>of<br>Comparison | Subject<br>Device | Predicate Device | Predicate Device | Predicate Device | Predicate<br>Device | Remark | |
| | | | | | | | |
| Intended Use | The device is<br>intended for<br>facial<br>stimulation by<br>electrode<br>heads for<br>cosmetic use.<br>The device is<br>also intended<br>for the<br>treatment of<br>periorbital<br>wrinkles with<br>red Light<br>Emitting Diode<br>(LED) head. It<br>is for over-the-<br>counter use. | 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>cosmetic 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>cosmetic use. | The<br>NOFACE®<br>Plus Facial Toning<br>Device is intended<br>for<br>facial<br>stimulation and is<br>indicated for over-<br>the-counter<br>cosmetic use. (21<br>CFR 801 Subpart<br>C). The anatomical<br>site for application<br>of the NOFACE®<br>Plus is the face. | The Nutra Light<br>Red is a non-<br>invasive LED<br>light device is<br>intended/indicate<br>d for over- the -<br>counter use for<br>the treatment of<br>periorbital<br>wrinkles, and<br>rhytides. | SE<br>Note 1 | |
| Apply parts | For micro<br>current<br>stimulation:<br>Face;<br>For Red light:<br>periorbital | Face | Face | Face | periorbital | SE | |
| Power<br>Sources | 1200mAh<br>lithium battery | One 6V battery | 9-Volt battery | 4 rechargeable<br>batteries | Internal NI-MH<br>rechargeable<br>battery | 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) | 1 | N/A | SE<br>Note 1 | |
| Number of<br>Channels for<br>Micro current<br>stimulation | 1 | 1 | 1 | 1 | N/A | SE | |
| Elements of<br>Comparison | Subject<br>Device | Predicate Device | Predicate Device | Predicate Device | Predicate Device | Remark | |
| -Synchronous<br>or Alternating | Alternating | N/A | Alternating | Alternating | N/A | SE Note 1 | |
| Regulated Current<br>or Regulated<br>Voltage | Regulated<br>Voltage | Both | 0-3mA (load 4kΩ) | Regulated Voltage | N/A | SE Note 1 | |
| Software/Firmware/Micropro<br>cessor control | Yes | Yes | Yes | Yes | Yes | SE | |
| Automatic<br>Overload Trip | Yes | Yes | Yes | Not required due to<br>circuit design | N/A | SE | |
| Automatic No-<br>load Trip | Yes. | Yes | Yes | Yes | N/A | SE | |
| Automatic<br>Shut Off | Yes. | Yes | Yes | Yes | N/A | SE | |
| Patient<br>Override<br>Control | Yes | Yes | N/A | Yes | N/A | SE | |
| On/<br>Off<br>Status | Yes | Yes | Yes | Yes | N/A | SE | |
| Indicator<br>or<br>Display | Low<br>Battery | Yes | Yes | Yes | Yes | N/A | SE |
| | Voltage/<br>Current<br>Level | Yes | Yes | Yes | Yes | N/A | SE |
| Timer Range | 10 minutes | None | 20, 40 minutes and<br>Continuous | 21 minutes | N/A | SE Note 1 | |
| Housing<br>Materials and<br>Construction | Console: ABS<br>plastic | Thermoplastic | ABS | Thermo Plastic | medical grade<br>biocompatibility<br>plastics via<br>injection molding | SE Note 1 | |
| Output Specification | | | | | | | |
| Elements<br>of<br>Comparison | Subject<br>Device | Predicate Device | Predicate Device | Predicate Device | Predicate<br>Device | Remark | |
| Waveform | Pulsed Biphasic | Biphasic | Biphasic | Pulsed Monoilhasic | N/A | SE<br>Note 2 | |
| Shape | Rectangular | Rectangular | Rectangular | Modulated Square | N/A | SE<br>Note 2 | |
| Maximum<br>Output<br>Voltage<br>(+/-<br>10%) | 1.23V @ 500Ω<br>3.64V @ 2kΩ<br>10.9V @ 10kΩ | 0.347V @ 500Ω<br>1.242V @ 2kΩ<br>5.780V @ 10kΩ | 1.78V @500Ω<br>6.64V @2KΩ<br>16.2V @10KΩ | 137mV @ 500Ω<br>769mV @ 2kΩ<br>3.82V @ 10kΩ | N/A | SE<br>Note 2 | |
| Maximum<br>Current<br>Density | 2.46mA @<br>500Ω<br>1.82mA @ 2kΩ<br>1.09mA @<br>10kΩ | 0.647mA @ 500Ω<br>0.625mA@ 2kΩ<br>0.584mA@ 10kΩ | 3.56mA @500Ω<br>3.32mA @2KΩ<br>1.62mA @10KΩ | 274μΑ @ 500Ω<br>387μA @ 2kΩ<br>382μΑ @ 10kΩ | N/A | SE<br>Note 2 | |
| Frequency<br>range | 59.3Hz | 0.62 1 - 308.6Hz | 8Hz, 9Hz, 10Hz | 8.40 Hz | N/A | SE<br>Note 2 | |
| Pulse<br>width<br>range | 4ms | 3.24-1610ms | N/A | 119ms | N/A | SE<br>Note 2 | |
| Pulse<br>duration | 4ms | 3.24-1610ms | ~49-63ms | N/A | N/A | SE<br>Note 2 | |
| Net Charge | 9.04μC@ 500Ω | 0 uC @5000 | N/A | N/A | N/A | SE<br>Note 2 | |
| Maximum<br>Phase<br>Charge | 16.4µC@ 500Ω | 190µC@ 500Ω | 157.12uC<br>(8Hz/500Ω) | 23.06µC@ 500Ω | N/A | SE<br>Note 2 | |
| Maximum<br>Current<br>Density | Bigger electrode<br>head:<br>0.044 mA/cm²@<br>500Ω<br>Smaller<br>electrode head:<br>0.42 mA/cm²@<br>500Ω | 1.486mA/cm²@<br>500Ω | 0.26mA/cm²<br>(8Hz/500Ω) | 0.419<br>mA/cm²@<br>500Ω | N/A | SE<br>Note 2 | |
| Maximum<br>Power<br>Density | Bigger<br>electrode head<br>0.014 mW/<br>cm²@ 500Ω<br>Smaller<br>electrode head<br>0.139 mW/<br>cm²@ 500Ω | 366 µW/cm² @<br>500Ω | 1.33mW/cm²<br>(8Hz/10kΩ) | 3.22 µW/cm² @<br>500Ω | - N/A | SE<br>Note 2 | |
| ON time | Constant | 10-30s | Constant | Constant | N/A | SE | |
| OFF time | None | 1-6s | None | None | N/A | SE | |
| Elements of<br>Comparison | Subject<br>Device | Predicate Device | Predicate Device | Predicate Device | Predicate<br>Device | Remark | |
| Contraction and<br>Relaxation time | Adjustable, due to different modes. | Adjustable, due to different modes. | -- | -- | N/A | SE | |
| For LED red light irradiation function | | | | | | | |
| LED<br>wavelength | 650+/-5nm | -- | -- | -- | 650 +/- 5nm | SE | |
| LED Power<br>Density | 80mW/cm² | -- | -- | -- | 80mW/cm² | SE | |
| Additional Features | | | | | | | |
| Environment<br>for operating | Temperature: 5 ~ 40° C | + 50 to 1040 F<br>(+10 to +40° C) | -- | -- | -- | SE | |
| Environment<br>for storage | Temperature: - 25 ~70° C<br>Humidity: 10 ~90% RH | - 29 to + 1670 F (- 34 to +76° C)<br>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 | |
| Electrical<br>Safety | 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"…
