(189 days)
Not Found
No
The summary describes a device with microcurrent and LED technology for facial stimulation and wrinkle treatment. There is no mention of AI or ML in the device description, intended use, or performance studies. The software validation mentioned is standard for medical devices and does not indicate AI/ML.
Yes
The device is intended for the "treatment of periorbital wrinkles," which implies a therapeutic purpose rather than solely cosmetic use.
No
The device is described as being for "facial stimulation" and "treatment of periorbital wrinkles," which are cosmetic and therapeutic uses, not diagnostic.
No
The device description explicitly mentions hardware components such as electrode heads, an LED lamp holder, an internal lithium rechargeable battery, and a USB cable for charging. It also describes physical mechanisms for stimulation (micro current and LED light). While software verification and validation are mentioned, the device is clearly not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is intended for "facial stimulation by electrode heads for cosmetic use" and "treatment of periorbital wrinkles with red Light Emitting Diode (LED) head." These are external applications to the body's surface and do not involve testing samples taken from the body.
- Lack of Sample Analysis: There is no mention of the device analyzing any biological samples. Its function is based on applying electrical currents and light to the skin.
Therefore, this device falls under the category of a medical device used for therapeutic and cosmetic purposes, not an In Vitro Diagnostic.
N/A
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.
Product codes
NFO, OHS
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
For micro current stimulation: Face; For Red light: periorbital
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-the-counter use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
K130045, K142794, K103472, K141308
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
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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3
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,
4
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
Technologies,
LIC. | EVERYWAY
MEDICAL
INSTRUMENT
CO., LTD. | Carol Cole
Company | Nutra Luxe MD,
LLC |
|----------------------|------------------------------------------------------|------------------------------------------------|-----------------------|-----------------------|
| Device
Name | Beautiful Image
Model 900 Facial
Toning Device | MT-200 Facial
MENS | NOFACE® Plus | Nutra Light Red |
| 510(k)
Number | K130045 | K142794 | K103472 | K141308 |
| Product
Code | NFO | NFO | NFO | OHS |
| Regulation
Number | 882.5890 | 882.5890 | 882.5890 | 878.4810 |
| Regulation
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.
5
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
of
Comparison | Subject
Device | Predicate Device | Predicate Device | Predicate Device | Predicate
Device | Remark | |
|-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|----|
| Basic Unit Characteristics | | | | | | | |
| Device Name
and Model | Micro-current
Wrinkle
Reduction
Facial Service,
model EP-400 | Beautiful
Image
Model 900
Facial
Toning Device | MT-200
MENS | NOFACE® Plus | Nutra Light Red | -- | |
| 510
(K)
Number | K162106 | K130045 | K142794 | K103472 | K141308 | -- | |
| Product Code | NFO, OHS | NFO | NFO | NFO | OHS | -- | |
| Regulation
Number | 882.5890
878.4810 | 882.5890 | 882.5890 | 882.5890 | 878.4810 | -- | |
| Elements
of
Comparison | Subject
Device | Predicate Device | Predicate Device | Predicate Device | Predicate
Device | Remark | |
| | | | | | | | |
| Intended 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. | Biosonic
Technologies
Model 900 Facial
Toning Device is
intended for facial
stimulation and is
indicated for
prescription
cosmetic use. The
anatomical site for
application of the
Model 900 is the
face. | The
Everyway
Facial
MENS,
model: MT-200 is
intended for facial
stimulation
and
indicated for over-
the-counter
cosmetic use. | The
NOFACE®
Plus Facial Toning
Device is intended
for
facial
stimulation and is
indicated for over-
the-counter
cosmetic use. (21
CFR 801 Subpart
C). The anatomical
site for application
of the NOFACE®
Plus is the face. | The Nutra Light
Red is a non-
invasive LED
light device is
intended/indicate
d for over- the -
counter use for
the treatment of
periorbital
wrinkles, and
rhytides. | SE
Note 1 | |
| Apply parts | For micro
current
stimulation:
Face;
For Red light:
periorbital | Face | Face | Face | periorbital | SE | |
| Power
Sources | 1200mAh
lithium battery | One 6V battery | 9-Volt battery | 4 rechargeable
batteries | Internal NI-MH
rechargeable
battery | SE
Note 1 | |
| Method of Line
Current
Isolation | Battery Supply
N/A | N/A | Type BF | N/A | N/A | SE
Note 1 | |
| For Micro current facial stimulation function | | | | | | | |
| Number of
Modes for
Micro current
stimulation | 1 | 1 | 3 (8Hz, 9Hz, 10Hz) | 1 | N/A | SE
Note 1 | |
| Number of
Channels for
Micro current
stimulation | 1 | 1 | 1 | 1 | N/A | SE | |
| Elements of
Comparison | Subject
Device | Predicate Device | Predicate Device | Predicate Device | Predicate Device | Remark | |
| -Synchronous
or Alternating | Alternating | N/A | Alternating | Alternating | N/A | SE Note 1 | |
| Regulated Current
or Regulated
Voltage | Regulated
Voltage | Both | 0-3mA (load 4kΩ) | Regulated Voltage | N/A | SE Note 1 | |
| Software/Firmware/Micropro
cessor control | Yes | Yes | Yes | Yes | Yes | SE | |
| Automatic
Overload Trip | Yes | Yes | Yes | Not required due to
circuit design | N/A | SE | |
| Automatic No-
load Trip | Yes. | Yes | Yes | Yes | N/A | SE | |
| Automatic
Shut Off | Yes. | Yes | Yes | Yes | N/A | SE | |
| Patient
Override
Control | Yes | Yes | N/A | Yes | N/A | SE | |
| On/
Off
Status | Yes | Yes | Yes | Yes | N/A | SE | |
| Indicator
or
Display | Low
Battery | Yes | Yes | Yes | Yes | N/A | SE |
| | Voltage/
Current
Level | Yes | Yes | Yes | Yes | N/A | SE |
| Timer Range | 10 minutes | None | 20, 40 minutes and
Continuous | 21 minutes | N/A | SE Note 1 | |
| Housing
Materials and
Construction | Console: ABS
plastic | Thermoplastic | ABS | Thermo Plastic | medical grade
biocompatibility
plastics via
injection molding | SE Note 1 | |
| Output Specification | | | | | | | |
| Elements
of
Comparison | Subject
Device | Predicate Device | Predicate Device | Predicate Device | Predicate
Device | Remark | |
| Waveform | Pulsed Biphasic | Biphasic | Biphasic | Pulsed Monoilhasic | N/A | SE
Note 2 | |
| Shape | Rectangular | Rectangular | Rectangular | Modulated Square | N/A | SE
Note 2 | |
| Maximum
Output
Voltage
(+/-
10%) | 1.23V @ 500Ω
3.64V @ 2kΩ
10.9V @ 10kΩ | 0.347V @ 500Ω
1.242V @ 2kΩ
5.780V @ 10kΩ | 1.78V @500Ω
6.64V @2KΩ
16.2V @10KΩ | 137mV @ 500Ω
769mV @ 2kΩ
3.82V @ 10kΩ | N/A | SE
Note 2 | |
| Maximum
Current
Density | 2.46mA @
500Ω
1.82mA @ 2kΩ
1.09mA @
10kΩ | 0.647mA @ 500Ω
0.625mA@ 2kΩ
0.584mA@ 10kΩ | 3.56mA @500Ω
3.32mA @2KΩ
1.62mA @10KΩ | 274μΑ @ 500Ω
387μA @ 2kΩ
382μΑ @ 10kΩ | N/A | SE
Note 2 | |
| Frequency
range | 59.3Hz | 0.62 1 - 308.6Hz | 8Hz, 9Hz, 10Hz | 8.40 Hz | N/A | SE
Note 2 | |
| Pulse
width
range | 4ms | 3.24-1610ms | N/A | 119ms | N/A | SE
Note 2 | |
| Pulse
duration | 4ms | 3.24-1610ms | ~49-63ms | N/A | N/A | SE
Note 2 | |
| Net Charge | 9.04μC@ 500Ω | 0 uC @5000 | N/A | N/A | N/A | SE
Note 2 | |
| Maximum
Phase
Charge | 16.4µC@ 500Ω | 190µC@ 500Ω | 157.12uC
(8Hz/500Ω) | 23.06µC@ 500Ω | N/A | SE
Note 2 | |
| Maximum
Current
Density | Bigger electrode
head:
0.044 mA/cm²@
500Ω
Smaller
electrode head:
0.42 mA/cm²@
500Ω | 1.486mA/cm²@
500Ω | 0.26mA/cm²
(8Hz/500Ω) | 0.419
mA/cm²@
500Ω | N/A | SE
Note 2 | |
| Maximum
Power
Density | Bigger
electrode head
0.014 mW/
cm²@ 500Ω
Smaller
electrode head
0.139 mW/
cm²@ 500Ω | 366 µW/cm² @
500Ω | 1.33mW/cm²
(8Hz/10kΩ) | 3.22 µW/cm² @
500Ω | - N/A | SE
Note 2 | |
| ON time | Constant | 10-30s | Constant | Constant | N/A | SE | |
| OFF time | None | 1-6s | None | None | N/A | SE | |
| Elements of
Comparison | Subject
Device | Predicate Device | Predicate Device | Predicate Device | Predicate
Device | Remark | |
| Contraction and
Relaxation time | Adjustable, due to different modes. | Adjustable, due to different modes. | -- | -- | N/A | SE | |
| For LED red light irradiation function | | | | | | | |
| LED
wavelength | 650+/-5nm | -- | -- | -- | 650 +/- 5nm | SE | |
| LED Power
Density | 80mW/cm² | -- | -- | -- | 80mW/cm² | SE | |
| Additional Features | | | | | | | |
| Environment
for operating | Temperature: 5 ~ 40° C | + 50 to 1040 F
(+10 to +40° C) | -- | -- | -- | SE | |
| Environment
for storage | Temperature: - 25 ~70° C
Humidity: 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 | |
| Electrical
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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7
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9
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
10
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.