Galvanic Spa, Model: SKB-1405

K163470 · Shenzhen Siken 3D Technology Development Co., Ltd. · NFO · Jun 2, 2017 · Neurology

Device Facts

• Record ID: K163470
• Device Name: Galvanic Spa, Model: SKB-1405
• Applicant: Shenzhen Siken 3D Technology Development Co., Ltd.
• Product Code: NFO · Neurology
• Decision Date: Jun 2, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Galvanic Spa (Model: SKB-1405) is intended for facial stimulation and is indicated for over-the-counter cosmetic use. The anatomical site for application of the Galvanic Spa is the face.

Device Story

Non-invasive facial toning device; delivers micro-current (0-390 μA) via dual stainless steel probes to face. User-operated for personal beauty purposes. Device features 4 intensity levels indicated by LEDs; powered by 3.7V Li-battery. Micro-current modality aims to increase facial contour and firm skin/muscles. Device includes automatic overload/no-load trip and auto-shutoff. Healthcare providers do not use output; device is for consumer self-use. Benefits include aesthetic facial firming.

Clinical Evidence

Bench testing only. Evidence includes electrical safety (IEC 60601-1, IEC 60601-2-10), electromagnetic compatibility (IEC 60601-1-2), software verification/validation, and waveform output parameter verification. Biocompatibility testing (cytotoxicity, sensitization, irritation) performed per ISO 10993-5 and ISO 10993-10; all tests passed.

Technological Characteristics

Micro-current stimulator; stainless steel electrodes; 3.7V Li-battery powered. Dimensions: 3.2" L x 6.5" W x 2.2" D. Output: pulsed, symmetric biphasic, rectangular waveform; 9.09 Hz frequency; 110 ms pulse duration. Type BF applied part. Software-controlled with 4 intensity levels. Biocompatibility per ISO 10993-1. Complies with IEC 60601-1, IEC 60601-2-10, and IEC 60601-1-2.

Indications for Use

Indicated for over-the-counter cosmetic facial stimulation. Not for use on injured or impaired skin/muscles, or for treatment/prevention of disease.

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

• NūFACE® Plus (K103472)

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 eagle with three heads in profile, facing right. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in all caps.

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

June 2, 2017

ShenZhen Siken 3D Technology Development Co., Ltd. % Mr. Jet Li Manager Guangzhou LETA Testing Technology Co., Ltd 6f, No.1 TianTai Road, Science City, LuoGang District GuangZhou, CN

Re: K163470

Trade/Device Name: Galvanic Spa, Model: SKB-1405 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NFO Dated: May 9, 2017 Received: May 15, 2017

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

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the quality systems (OS) 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

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) K163470

Device Name Galvanic Spa, Model: SKB-1405

Indications for Use (Describe)

The Galvanic Spa (Model: SKB-1405) is intended for facial stimulation and is indicated for over-the-counter cosmetic use. The anatomical site for application of the Galvanic Spa is the face.

| 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

## Date of the summary prepared: May 1, 2017

# 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. Submitter's Information

- � Company Name: ShenZhen Siken 3D Technology Development Co.,Ltd.
- � Address: Siken Industrial Park, East Avenue No.33 Songgang Street,Baoan District,Shenzhen,Guangdong,China
- Phone: [phone] �
- Fax: [phone] �
- Contact Person (including title): Kimi xue �
- E-mail: [e-mail] �

#### Subject Device Information 2.

- Galvanic Spa, Model: SKB-1405 � Trade Name:
- Galvanic Spa � Common Name:
- Stimulator, Transcutaneous Electrical, Aesthetic Purposes Classification name: �
- Neurology, Physical Medicine Review Panel: �
- NFO Product Code: �
- 2 Regulation Class: �
- 882.5890 Regulation Number: �

#### Predicate Device Information 3.

| Sponsor | Carol Cole Company |
|-------------------|--------------------|
| Device Name | NūFACE® Plus |
| 510(k) Number | K103472 |
| Product Code | NFO |
| Regulation Number | 882.5890 |

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| Sponsor: | ShenZhen Siken 3D Technology Development Co.,Ltd. |
|------------------|-----------------------------------------------------------|
| Subject Device: | Galvanic Spa,Model: SKB-1405 |
| File No.: | 510(k) submission report (V1.0), Chapter 6 510(k) Summary |
| Regulation Class | 2 |

# 4. Device Description

Galvanic Spa, Model: SKB-1405 is a non-invasive facial toning device intended for facial stimulation. It produces micro-current discharged through the dual probes that are designed for optimal contact with faces of all shapes and sizes.Micro-current is an aesthetic modality providing electric current in millionths of an ampere and has the ability to increase facial contour and firm the skin and muscles by supplying 0-390 μΑ.

Galvanic Spa, Model: SKB-1405 is not for use on injured or otherwise impaired skin or muscles, and in any therapy for the treatment, or prevention of any disease. This device is not for use near any devices with Electromagnetic Interference (EMI). This device must only be used for the purpose stated - namely for the stimulation of facial muscles as indicated in the instruction manual for personal beauty purposes. All other uses shall be deemed improper.

# 5. Intended Use / Indications for Use

The Galvanic Spa (Model: SKB-1405) is intended for facial stimulation and is indicated for over thecounter cosmetic use. The anatomical site for application of the Galvanic Spa is the face.

# 6.Design

Galvanic Spa, Model: SKB-1405 is intended for facial stimulation.It has one treatment mode which is micro-current mode.It produces micro-current discharged through the dual probes.The device measures 3.2" L x 6.5" W x 2.2" D. Its two output contacts are made by stainless steel. The device is powered by 3.7V Li-battery,and there are 4 output intensity levels which can be indicated by four LED lamps in the head of device.

# 7. Materials

There is one kind of patient directly contracting component in the subject device as the following list.

| Component of Device<br>Requiring<br>Biocompatibility | Material of<br>Component | Body Contact<br>Category<br>(ISO 10993-1) | Contact Duration<br>(ISO 10993-1) |
|------------------------------------------------------|--------------------------|-------------------------------------------|-----------------------------------|
| Electrodes | Stainless steel | Surface-contacting<br>device: skin | Maximum 2 hours<br>(< 24hours) |

(Note: The "Massage Head" described in the biocompatibility test reports is mean the electrodes, they are the same part of the device.)

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Sponsor: ShenZhen Siken 3D Technology Development Co.,Ltd. Galvanic Spa,Model: SKB-1405 Subject Device: File No.: 510(k) submission report (V1.0), Chapter 6 510(k) Summary

The Nature of body contact is surface, skin contact. And the contact duration is less than 24 hours. According to Table 1 - Initial evaluation tests for consideration in ISO 10993-1, the applicable biological effect is:

- � Cytotoxicity
- � Sensitization
- � Irritation or intracutaneous reactivity

### 1. Cytotoxicity Test

(1) Test Method

MTT Method in ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for In Vitro

cytotoxicity, Edition 3.0, 2009;

(2) Passing Criteria

As our subject device is only for limited skin contacting, we set the criteria for NON-TOXIC to be "no more than Grade 2" according to United States Pharmacopoeia.

(3) Test Result

The Cytotoxicity test result showed the device had no toxicity to L929 cell. The test result is passed the criteria.

### 2. Skin Sensitization Test

- (1) Test Method
Guinea Pig Maximization Test in ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization, Edition 3.0, 2010;

(2) Passing Criteria

As our subject device is for limited skin contacting, we set the criteria to be "Grade 0" according to United States Pharmacopoeia.

- (3) Test Result
The Skin Sensitization test result for device is Grade 0. The test result is passed the criteria.

### 3. Skin Irritation Test

(1) Test Method

0.9% Sodium Chlorid Injection and Sesame oil Extract in ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization, Edition 3.0, 2010;

(2) Passing Criteria

As our subject device is for limited skin contacting, we set the criteria to be "0-0.4 for Irritation Index" according to United States Pharmacopoeia.

(3) Test Result

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The Skin Irritation test results for Component is 0 for Irritation Index. The test result is passed the criteria.

### 8.Physical characteristics

| Basic Unit Characteristics | |
|-----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Power Source | 3.7V Li-battery |
| Method of Line Current Isolation | Type BF Applied Part |
| Patient leakage current | Comply with IEC 60601-1 and IEC 60601-2-10 |
| - Normal Condition | -- |
| - Single Fault Condition | -- |
| Average DC current through electrodes when device is on but no pulses are being applied | 0A |
| Number of channels | 1 |
| Number of modes | 1 |
| Output Intensity Level | 4 |
| Regulated Current or Regulated Voltage? | Current Control |
| Software/Firmware/Microprocessor Control? | Yes |
| Automatic Overload Trip? | Yes |
| Automatic No-Load Trip? | Yes |
| Automatic Shut Off? | Yes |
| User Override Control? | Yes |
| Indicator | Indicates on/off status, low battery, LED of mode information, intensity level information. |
| Time Range (minutes) | No |
| Compliance with Voluntary Standards | Yes<br>Comply with IEC 60601-1 and IEC 60601-2-10, IEC 60601-1-2 |
| Compliance* with 21 CFR 898 | Yes |
| Main Unit Weight | 248g |
| Accessories Weight | Charger Adapter: 180g |
| Main Unit Dimension | 3.2" L x 6.5" W x 2.2" D |
| Charger lead wire length | 1.6m |
| Housing Materials of main unit | Electrodes made from stainless steel. |
| Accessories Materials | Plastic |
| Micro-Current Mode Specification | |
| Waveform and Shape | Pulsed, symmetric biphasic, rectangular |
| Maximum Output Voltage (+/- 10%) | 156mV @ 500Ω<br>0.78V @ 2kΩ |
| | 2.6V @ 10kΩ |
| Maximum Output Current (+/- 10%) | 0.31mA @ 500Ω<br>0.39mA @ 2kΩ<br>0.26mA @ 10kΩ |
| Net Charge (per pulse) | 0 mC @500Ω |
| Phase Charge | 17.1 μC @ 500Ω |
| Maximum Current Density | 0.274mA/cm²@500Ω (The Electrode Size: 1.13 cm²) |
| Maximum Power Density | 42.5μW/cm²@500Ω(The Electrode Size:1.13cm²) |
| Pulse Width | 55 ms |
| Pulse Duration | 110 ms |
| Frequency | 9.09 Hz±10 % |
| Contraction and Relaxation Time | Due to different modes. (See below "Program Specification Table") |
| Additional Features | |
| Environment for operation | Temperature: 5 ~ 40°C<br>Humidity: ≤ 80% RH |
| Environment for storage | Temperature: 0 ~ 45°C<br>Humidity: ≤ 93% RH |

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Sponsor: ShenZhen Siken 3D Technology Development Co.,Ltd. Subject Device: Galvanic Spa,Model: SKB-1405 File No.: 510(k) submission report (V1.0), Chapter 6 510(k) Summary

# 9. Test Summary

Galvanic Spa, Model: SKB-1405 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
- � Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"
- � The waveform test report has also been conducted to verify the output parameters of the device.

# 10. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, materials, and intended use of Galvanic Spa, Model: SKB-1405 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 of<br>Comparison | Subject Device | Predicate Device | Remark | |
|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|--------------|
| Device Name and<br>Model | Galvanic Spa,<br>Model: SKB-1405 | NūFACE® Plus | -- | |
| 510(k) Number | Applying | K103472 | -- | |
| Elements of<br>Comparison | Subject Device | Predicate Device | Remark | |
| Manufacturer | ShenZhen Siken 3D Technology<br>Development Co.,Ltd. | Carol Cole Company | -- | |
| Intended Use | The Galvanic Spa (Model: SKB-<br>1405) is intended for facial<br>stimulation and is indicated for over-<br>the-counter cosmetic use. The<br>anatomical site for application of the<br>Galvanic Spa is the face. | The NūFACE® Plus Facial Toning<br>Device is intended for facial stimulation<br>and is indicated for<br>over-the-counter cosmetic use. (21<br>CFR 801 Subpart C).<br>The anatomical site for application of<br>the NOFACE® Plus is the face. | SE | |
| Power Source(s) | 3.7V Li-battery | 4 rechargeable AA NiMH batteries | SE<br>Note 1 | |
| Method of Line<br>Current Isolation | Type BF Applied Part | Type BF Applied Part | SE | |
| Patient<br>Leakage<br>Current | Comply with IEC 60601-1 and IEC<br>60601-2-10 | Comply with IEC 60601-1 and IEC<br>60601-2-10 | SE | |
| | NC<br>SFC | | | |
| Average DC<br>current through<br>electrodes when<br>device is on but<br>no pulses are<br>being applied | 0 | 0 | SE | |
| Number of Output<br>Channels | One channel | One channel | SE | |
| Number of Output<br>Modes | one mode | one mode | SE | |
| Output Intensity<br>Level | 4 levels | 3 levels | SE<br>Note 3 | |
| Synchronous or<br>Alternating? | Alternating | Alternating | SE | |
| Regulated Current<br>or Regulated<br>Voltage? | Both | Both | SE | |
| Elements of<br>Comparison | | Subject Device | Predicate Device | Remark |
| Software/Firmware/Microprocessor<br>Control? | | Yes | Yes | SE |
| Automatic<br>Overload Trip | | Yes | Not required due to circuit design | SE<br>Note 1 |
| Automatic No-<br>Load Trip | | Yes | Yes | SE |
| Automatic Shut<br>Off | | Yes | Yes | SE |
| Patient Override<br>Control | | Yes | Yes | SE |
| Indicator<br>Display | On/Off<br>Status | Yes | Yes | SE |
| | Low<br>Battery | No | Yes | SE<br>Note 1 |
| | Voltage/<br>Current<br>Level | Yes | Yes | SE |
| Timer Range | | No | Yes(21 minutes) | SE<br>Note 3 |
| LCD Display | | No | No | SE |
| Compliance with<br>Voluntary<br>Standards | | Yes<br>Comply with IEC 60601-1 and IEC<br>60601-2-10, IEC 60601-1-2 | Yes<br>Comply with IEC 60601-1 and IEC<br>60601-2-10, IEC 60601-1-2 | SE |
| Compliance* with<br>21 CFR 898 | | Yes | Yes | SE |
| Weight | | 248g | 9 oz without charging base | SE<br>Note 2 |
| Dimensions | | 3.2" L x 6.5" W x 2.2" D | 3" x 5.25" x 1.25"(inch) | SE<br>Note 2 |
| Housing Materials<br>and Construction | | Thermo Plastic | Thermo Plastic | SE |
| Output Specifications | | | | |
| Elements of<br>Comparison | Subject Device | Predicate Device | Remark | |
| Waveform | Pulsed Biphasic | Pulsed Monophasic | SE<br>Note 3 | |
| Shape | Symmetric biphasic, rectangular | Modulated Square | SE<br>Note 3 | |
| Maximum Output<br>Voltage (+/- 10%) | 156mV @ 500Ω<br>0.78V @ 2kΩ<br>2.6V @ 10kΩ | 137mV @ 500Ω<br>769mV @ 2kΩ<br>3.82V @ 10kΩ | SE<br>Note 3 | |
| Maximum Output<br>Current (+/- 10%) | 0.31mA @ 500Ω<br>0.39mA @ 2kΩ<br>0.26mA @ 10kΩ | 274uA @ 500Ω<br>387uA @ 2kΩ<br>383uA @ 10kΩ | SE<br>Note 3 | |
| Pulse Duration | 110ms | 119 ms | SE<br>Note 3 | |
| Pulse Frequency | 9.09 Hz±10 % | 8.40 Hz | SE<br>Note 3 | |
| Maximum Current<br>Density | 0.274mA/cm2@500Ω | 0.419mA/cm2@500Ω | SE<br>Note 4 | |
| Maximum Power<br>Density | 42.5μW/cm2@500Ω | 3.22μW/cm2@500Ω | SE<br>Note 4 | |
| Contraction and<br>Relaxation Time | Adjustable, due to different levels.<br>(See below "Program Specification<br>Table") | Adjustable, due to different levels. | SE | |
| Environment for<br>Operating | Temperature: 5°C~40°C<br>Humidity: ≤80 % | Temperature: 5 ~ 40° C<br>Humidity: 20 ~ 65% RH | SE<br>Note 1 | |
| Environment for<br>Storage | Temperature:0~45°C<br>Humidity: ≤93% | Temperature: 0 ~ 40°C<br>Humidity: 10 ~ 90% RH | SE<br>Note 1 | |
| Biocompatibility | All user directly contacting materials<br>are compliance with ISO10993-5<br>and ISO10993-10 requirements. | All user directly contacting materials<br>are compliance with ISO10993-5 and<br>ISO10993-10 requirements. | SE | |
| Electrical Safety | Comply with IEC 60601-1, IEC<br>60601-2-10, | Comply with IEC 60601-1 and IEC<br>60601-2-10 | SE | |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SE | |

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#### Sponsor: ShenZhen Siken 3D Technology Development Co.,Ltd. Subject Device: Galvanic Spa,Model: SKB-1405 File No.: 510(k) submission report (V1.0), Chapter 6 510(k) Summary

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#### Sponsor: ShenZhen Siken 3D Technology Development Co.,Ltd. Subject Device: Galvanic Spa,Model: SKB-1405 File No.: 510(k) submission report (V1.0), Chapter 6 510(k) Summary

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#### Sponsor: ShenZhen Siken 3D Technology Development Co.,Ltd. Subject Device: Galvanic Spa,Model: SKB-1405 File No.: 510(k) submission report (V1.0), Chapter 6 510(k) Summary

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# Comparison in Detail(s):

# Note 1:

"Power Source(s)", "Automatic Overload Trip", "Operating Environment", "Storage Environment","Housing Materials and Construction" and "Indicator Display of Low Battery and Voltage/ Current Level"are a little different from the predicate devices, it will not affect the main function and the intended use of the device. They all also comply with IEC 60601-1 requirements. So the differences will not raise any safety or effectiveness issue.

# Note 2:

Although the "Weight", "Dimensions" of subject device are different from the predicate devices, they are all proved by waveform report and performance report. And they comply with IEC 60601-2-10 requirements. So the differences of the physics specifications will not raise any safety or effectiveness issue.

# Note 3:

Although the "Waveform", "Maximum Output Current", "Maximum Output Voltage", "Pulse Duration", "Output Intensity Level","Timer Range","Shape", "Maximum Current Density", "Maximum Power Density"and "Pulse Frequency" of subject device are a little different from the predicate devices, they all comply with IEC 60601-1, IEC 60601-2-10 requirement, So the differences of function specification will not raise any safety or effectiveness issue.

# Note 4:

The subject device and the predicate device has the same intended use and the similar technological characteristics of output waveform. And the power density of the subject device and predicate device both conform to FDA Guidance: Maximum Power Density < 0.25 (W/cm²), and they all comply with IEC60601-1, IEC60601-2-10, so the value of the subject device does not adversely impact safety and effectiveness compared to values of the predicate device.