K Number

Device Name

Micro-current facial cold and hot service (model: TPML-100)

Manufacturer

Li-Tek Electronics Technology C0., Ltd

Date Cleared

2022-05-25

(245 days)

Product Code

OLP NFO

Regulation Number

878.4810

Intended Use

Micro-current vibration facial cold and hot service is an over the counter device that is indicated for the treatment of mild to moderate inflammatory acne and facial stimulation for the over the counter aesthetic use.

Device Description

The Micro-current vibration facial cold and hot service device (Model: TPML-100) is a hand-held, non-sterile, reusable device designed to achieve the aesthetic effect. It consists of main unit, and USB cable. The device is supplied by internal rechargeable lithium battery, which can be recharged by external charger through the USB cable. The device is un-usable when charging. The device is only home environment use, which has three metal heads (Dual / Single), and two LED light windows (Red / Blue) to provides following functions: a) EMS (micro current output stimulation) function. The device generates a low-frequency micro-current on the Dual Heads which will applied in the facial skin to do facial stimulation. b) Red and Blue LED irradiation function. The device outputs the red light at the wavelength of 630 ± 10 nm and the blue light at the wavelength of 415 ± 10 nm to apply the light in narrow spectral bandwidth on facial skin to treat mild to moderate acne. c) Vibration function. The device generates different patterns of micro-vibration by a builtin micro motor to relax the facial skin. (This function is classified as class I and not need for 510K.) d) Warming and Cooling function. The device heats Dual Heads up to 44 ± 2 °C or cool the Single Head down to 10 ± 2 °C, to relax the facial skin with a warm or cold sensation. (This function is not for medical purpose.)

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K180900, K201906, K162652

Reference Devices

K191951

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details standard physical and electrical functions (micro-current, LED, vibration, heating/cooling) and mentions no computational or adaptive elements indicative of AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".

Therapeutic

Yes
The device is indicated for the treatment of mild to moderate inflammatory acne, which is a medical condition, thus classifying it as a therapeutic device.

Diagnostic

The device is indicated for the treatment of mild to moderate inflammatory acne and facial stimulation for aesthetic use. It is a therapy device, not a diagnostic one.

SaMD (Software as a Medical Device)

The device description clearly outlines a physical, hand-held device with hardware components such as metal heads, LED lights, a micro motor, and a battery. It is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
Device Function: The description clearly states the device is a "Micro-current vibration facial cold and hot service" device that applies functions directly to the facial skin (EMS, LED irradiation, vibration, warming/cooling). It does not involve the analysis of specimens taken from the body.
Intended Use: The intended use is for "treatment of mild to moderate inflammatory acne and facial stimulation for the over the counter aesthetic use." This is a direct treatment and aesthetic application, not a diagnostic process based on analyzing bodily samples.

Therefore, this device falls under the category of a therapeutic or aesthetic device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

OLP, NFO

Device Description

The Micro-current vibration facial cold and hot service device (Model: TPML-100) is a hand-held, non-sterile, reusable device designed to achieve the aesthetic effect. It consists of main unit, and USB cable. The device is supplied by internal rechargeable lithium battery, which can be recharged by external charger through the USB cable. The device is un-usable when charging. The device is only home environment use, which has three metal heads (Dual / Single), and two LED light windows (Red / Blue) to provides following functions:
a) EMS (micro current output stimulation) function. The device generates a low-frequency micro-current on the Dual Heads which will applied in the facial skin to do facial stimulation.
b) Red and Blue LED irradiation function. The device outputs the red light at the wavelength of 630 ± 10 nm and the blue light at the wavelength of 415 ± 10 nm to apply the light in narrow spectral bandwidth on facial skin to treat mild to moderate acne.
c) Vibration function. The device generates different patterns of micro-vibration by a builtin micro motor to relax the facial skin. (This function is classified as class I and not need for 510K.)
d) Warming and Cooling function. The device heats Dual Heads up to 44 ± 2 °C or cool the Single Head down to 10 ± 2 °C, to relax the facial skin with a warm or cold sensation. (This function is not for medical purpose.)

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

facial skin (face, neck)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Home environment use / 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

Lab bench testing as following:

IEC 60601-1:2012 , Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility
IEC 60601-1-11:2015 Medical electrical equipment - part 1-11: general requirements for basic safety and essential performance - collateral standard: requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
IEC 60601-2-10:2012 AMD1:2016 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
IEC 60601-2-57:2011 Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
ISO 10993-5:2009, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity
ISO 10993-10:2010, Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
No Clinical Test conducted.
Usability testing was conducted to demonstrate that the device and its labeling can meet the following requirements:

the lay user can self-select themselves as being appropriate users of this device by the external box labeling,
the lay user can apply the treatment safely and correctly according to the instructions for use, and
the lay user can understand all indications, contraindications, warnings and precautions, and be able to identify whether they are within any contraindicated group; and be able to understand the user manual.

Key Metrics

Not Found

Predicate Device(s)

K180900, K201906, K162652

Reference Device(s)

K191951

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

Summary

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

May 25, 2022

Li-Tek Electronics Technology C0., Ltd % Jet Li Regulation manager Guangdong Jianda Medical Technology Co., Ltd. 6F, No.1 TianTai road, Science City, LuoGang District Guangzhou, Guangdong China

Re: K213039

Trade/Device Name: Micro-current facial cold and hot service (model: TPML-100) Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: OLP, NFO Dated: March 29, 2022 Received: April 15, 2022

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K213039

Device Name

Micro-current vibration facial cold and hot service (model: TPML-100)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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Date of the summary prepared: May 24, 2022

510(k) Summary

K213039

This summary of 510(K) safety and effectiveness information is being submitted in

accordance with the requirement of 21 CFR 807.92. This is a Traditional 510(K) submission,

and there were no prior submissions for the subject device.

1. Submitter's Information

Sponsor

� Company Name: Li-Tek Electronics Technology Co., Ltd.
Address: No. 8~13, the industrial park of Jinshagang, Shixia village, Dalang town, � Dongguan city, Guangdong, China
� Phone: + 86-769-83117755
� Email: quality5@li-tek.com
Contact Person (including title): Barry Yuan (Quality Director) �

Application Correspondent:

� Guangdong Jianda Medical Technology Co., Ltd.
� Address: 6F, No.1 TianTai road, Science City, LuoGang District, GuangZhou City, China
� Contact Person: Mr. Jett Lee
Title: Regulation Manager �
� Tel: +86-13512755282
� Email: jianda-lee@foxmail.com

2. Subject Device Information

� 510(k) number: K213039
� Type of 510(k) submission: Traditional
Classification: Over-The-Counter Powered Light Based Laser For Acne; �

Transcutaneous electrical nerve stimulator for pain relief

Trade Name: Micro-current vibration facial cold and hot service �
- Model: TPML-100 �
- Review Panel: General& Plastic Surgery / Neurology �
- � Product Code: OLP / NFO
- � Regulation Number: 21 CFR 878.4810 / 882.5890
- � Requlation Class: 2

3. Predicate Device Information

Primary Predicate Device I

510(k) number: K180900 �
� Sponsor: UVBIOTEK, LLC
� Classification: Over-The-Counter Powered Light Based Laser For Acne
� Trade Name: LED Light Therapy Device, Model: KN-7000C
� Review Panel: General & Plastic Surgery
� Product Code: OLP
Regulation Number: 21 CFR 878.4810 �
Regulation Class: 2 �

Secondary Predicate Device II

510(k) number: K201906 �
� Sponsor: LG Electronics, Inc.
� Classification: Transcutaneous electrical nerve stimulator for pain relief
� Trade Name: Trinity ELE Plus Facial Toning Device
� Model: Trinity ELE Plus
� Review Panel: Neurology
Product Code: NFO �
Regulation Number: 21 CFR 882.5890 �
� Regulation Class: 2

Predicate Device III

510(k) number: K162652 �
� Sponsor: Li-tek Electronic Technology Corporation.
Classification: Transcutaneous electrical nerve stimulator for pain relief �
� Trade Name: Smart Photon Micro-current Device
� Model: EP-300
� Review Panel: Neurology
Product Code: NFO �
� Regulation Number: 21 CFR 882.5890
� Regulation Class: 2

Reference Device

� 510(k) number: K191951
� Sponsor: Avazzia, Inc.
� Classification: Transcutaneous electrical nerve stimulator for pain relief
� Trade Name: Avazzia OTC TENS for aesthetics
Model: BEST-AV1TM: EZZI-LIFTT™ Device �
Review Panel: Neurology �
� Product Code: NFO
� Regulation Number: 21 CFR 882.5890
� Regulation Class: 2

4. Device Description

The device is only home environment use, which has three metal heads (Dual / Single), and two LED light windows (Red / Blue) to provides following functions:

a) EMS (micro current output stimulation) function. The device generates a low-frequency micro-current on the Dual Heads which will applied in the facial skin to do facial stimulation.
b) Red and Blue LED irradiation function. The device outputs the red light at the wavelength of 630 ± 10 nm and the blue light at the wavelength of 415 ± 10 nm to apply the light in narrow spectral bandwidth on facial skin to treat mild to moderate acne.
c) Vibration function. The device generates different patterns of micro-vibration by a builtin micro motor to relax the facial skin. (This function is classified as class I and not need for 510K.)
d) Warming and Cooling function. The device heats Dual Heads up to 44 ± 2 °C or cool the Single Head down to 10 ± 2 °C, to relax the facial skin with a warm or cold sensation. (This function is not for medical purpose.)

5. Intended Use / Indications for Use

6. Test Summary

Micro-current vibration facial cold and hot service has been evaluated for its safety and performance by lab bench testing as following:

� IEC 60601-1:2012 , Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
� IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility

� IEC 60601-1-11:2015 Medical electrical equipment - part 1-11: general requirements for basic safety and essential performance - collateral standard: requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
� IEC 60601-2-10:2012 AMD1:2016 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
� IEC 60601-2-57:2011 Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
� ISO 10993-5:2009, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity
� ISO 10993-10:2010, Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization

7. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, materials, and intended use of Micro-current facial cold and hot service is substantially equivalent to the predicate devices quoted above. Even there is minor difference on output waveform parameters and construction between subject device and predicate device. But the differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

Micro-current vibration facial cold and hot service, Model: TPML-100 Subject Device:

Device	Proposed Device	Predicate Device I	Predicate Device II	Predicate Device III	Reference Device
		Primary	Secondary	Secondary
510(K)	K213039	K180900	K201906	K162652	K191951
Manufacturer	Li-Tek Electronics
Technology Co., Ltd	Uvbiotek, LLC	Carol Cole Company dba
NūFACE	Li-Tek Electronics
Technology Co., Ltd	Avazzia, Inc
Product
Name	Micro-current vibration
facial cold and hot service
TPML-100	LED Light Therapy Device
KN-7000C	Trinity ELE Plus Facial
Toning Device
Trinity ELE Plus	Smart Photon Micro-
current Device EP-300	Avazzia OTC TENS for
Aesthetics
BEST-AV1
EZZI-LIFT Device
Classification	Class II, OLP / NFO
21
CFR878.4810/882.5890	Class II, OLP
21 CFR878.4810	Class II, NFO
21 CFR 882.5890	Class II, NFO/OHS/OLP
21 CFR 882.5890	Class II, NFO
21 CFR 882.5890
Prescription/
OTC	OTC	OTC	OTC	OTC	OTC
Intended Use	Micro-current facial cold
and hot service is an over
the counter device that is
indicated for the treatment
of mild to moderate
inflammatory acne and
facial stimulation for the
over the counter aesthetic
use.	LED Light Therapy Device
is indicated for the
treatment of mild to
moderate inflammatory
acne.	The Trinity ELE Plus and
Trinity ELE Plus Pro are
intended for facial
stimulation and are
indicated for over the
counter cosmetic use.	For micro current
Stimulation mode: The
device is intended for
Facial stimulation and is
indicated for over-the
counter aesthetic use.	The Avazzia OTC TENS
for aesthetics, model
BEST-AV1TM: EZZI-
LIFTTM Device is indicated
for over-the-counter
aesthetic use including
facial and neck
stimulation or body skin
stimulation.
Power Supply	Charger (not included)
input: DC 5V, 1A	Adapter Input: 100-240V
a.c. 50/60Hz, 0.5A max.	Unknown	3.7V, 800mAh
rechargeable
lithium battery	3V
	Internal battery: 3.7Vd.c.
900mAh	Adapter Output: 5V d.c.
2A
Main unit input: 5V d.c.
2A/ Internal battery:
3.6Vd.c. 2200mAh
Battery	Lithium-ion	Lithium-ion	Lithium-ion	Lithium-ion	2* 1.5 V AA batteries
Software
Control	YES	YES	YES	YES	YES
Handheld	YES	YES	YES	YES	YES
Effective
irradiance	Blue light: 25 mw/cm²
±10%
Red light: 45 mw/cm²±10%	Blue light: 25±5 mw/cm²
Red light: 45±5 mw/cm²	/	/	/
LED Amount	6 red LEDs
4 blue LEDs	48 red LEDs
48 blue LEDs	/	/	/
Wavelength	Blue light: 415±10 nm
Red light: 630±10 nm	Blue light: 417±10 nm
Red light: 633±10 nm	/	/	/
Energy
Output	User adjustable for EMS	/	User adjustable, variable output frequency, microcurrent continuously alternates and delivered via dual chrome-plated precise wands	User adjustable for EMS	/
Special
Requirements	No	No	Requires Conductive Gel	Requires Conductive Gel	No

Micro-current vibration facial cold and hot service, Model: TPML-100 Subject Device:

| Waveform | Bi-phase square-wave | / | Pulsed Biphasic,
Modulated Square | Bi-phase square-wave | positive square wave
followed by a damped
sinusoidal waveformof |
|-------------------------------|---------------------------------------------------------------|---|------------------------------------------------------------------------------------------|------------------------------------------------|---------------------------------------------------------------------------|
| Type | pulse | / | | pulse | variable duration
depending on damping
and body loading |
| Maximum | 225 mV @500Ω, ±10% | | 170 mV @500Ω, ±10% | 1.49V @ 500Ω | -42V @ 500Ω |
| Output | 900 mV @2kΩ, ±10% | / | 688 mV @2kΩ, ±10% | 2.48V @ 2kΩ | -122V @ 2kΩ |
| Voltage | 3.86 V @10kΩ, ±10% | | 3.4 V @10kΩ, ±10% | 10.6V @ 10kΩ | -348V @ 10kΩ |
| Maximum
Output
Current | 450 μA @500Ω, ±10%
450 μA @2kΩ, ±10%
386 μA @10kΩ, ±10% | | 243 μA @500Ω, ±10%
245 μA @2kΩ, ±10%
246 μA @10kΩ, ±10% | 2.98mA @ 500Ω
1.24mA @ 2kΩ
1.06mA @ 10kΩ | 500 μA
363 μA @500Ω, ±20%
117 μA @2kΩ, ±20%
38 μA @10kΩ, ±20% |
| Pulse Period
(Pulse Width) | 4ms | / | Varies w/Frequency
(60 msec @ 8.33Hz) | 4ms | 1.1 |
| Output
Frequency
(Hz) | 57±3Hz | / | 0.3 - 50 Hz
(Default 8.3 Hz) | 60Hz | 15 to 121 |
| Net Charge | 0 μC @ 500Ω | / | 0 μC @ 500Ω | 0 μC @ 500Ω | 4 μC @ 500Ω |
| Maximum
current
density | 0.49mA/cm²@500Ω | / | Trinity ELE Plus
0.947 mA/cm² @ 10k Ω
Trinity ELE Plus Pro
1.165 mA/cm² @ 10k Ω | 0.524mA/cm²
@500Ω | Built-in, Y, Brush:
800 μA/cm² @500Ω
Pencil:
19,000 μA/cm² @500Ω |
| Maximum
Power | 0.20mW/cm²@ 500Ω | / | Trinity ELE Plus
2.331 mW/cm² @ 10k Ω | 0.216mW/cm²
@500Ω | Built-in, Y, Brush:
500μW/cm² @500Ω |

Micro-current vibration facial cold and hot service, Model: TPML-100 Subject Device:

Density			Trinity ELE Plus Pro		Pencil:
			$3.525 mW/cm² @ 10K Ω$		$3,500μW/cm² @500Ω$
Treatment
recommendat
ion	Hold treatment face in
contact with skin.
Apply blue light for
3 minutes per skin area,
followed by red light for 3
minutes per skin area.
Can be used daily.
Apply EMS micro-current
for 15 minutes per day.
Can be used for 2-3 times
per week.	Hold treatment face in
contact with skin. Apply
blue light for 3 minutes per
skin area, followed by red
light for 3 minutes per skin
area. Can be used daily.	Unknown	15 minutes	max duration of use:
60 minutes
Main
Materials	PC, ABS, Stainless steel
(SUS 304)	Rigid ABS
Polycarbonate lens cover	ABS Thermoplastic
Chromium	PC, ABS, Stainless steel
(SUS 304)	Stainless steel 316
Dimension	188(L)×50(W)×55(H)mm	257mm×165mm×70mm
(10.1in×6.5in×2.8in)	6.1" H x 2.4" W x 1.2" D	--	2.6" X 4.7" X 1.35"
Net Weight	233 g	174g (6.1 oz)	Unknown	--	5.4 ounces
Safety and
EMC	IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 60601-2-10
IEC 60601-2-57	IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 60601-2-57	IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11	IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 60601-2-10
IEC 60601-2-57	IEC 60601-1
IEC 60601-1-2
IEC 60601-2-10
ISO 14971
IEC 62366
Biocompatibil
ity	ISO 10993-5
ISO 10993-10	ISO 10993-5
ISO 10993-10	ISO 10993-5
ISO 10993-10	ISO 10993-5
ISO 10993-10	/

8. Summary for clinical test

No Clinical Test conducted.

9. Usability Testing

Usability testing was conducted to demonstrate that the device and its labeling can meet the following requirements:

the lay user can self-select themselves as being appropriate users of this device by the external box labeling,
the lay user can apply the treatment safely and correctly according to the instructions for use, and
the lay user can understand all indications, contraindications, warnings and precautions, and be able to identify whether they are within any contraindicated group; and be able to understand the user manual.

10. Conclusion

The subject device Micro-current vibration facial cold and hot service has all features of the predicate devices for intended use. The few differences do not affect the safety and effectiveness of the subject device. Thus, the subject device is substantially equivalent to the predicate devices.