(172 days)
Not Found
No
The document does not mention AI, ML, or any related concepts like algorithms that adapt or learn. The device description focuses on micro-current technology and standard electrical and software testing.
No
Explanation: The device is described as being for "cosmetic use" and "personal beauty purposes" for "facial stimulation" and "toning" to "firm the skin and muscles", explicitly stating it's "not for use...in any therapy for the treatment, or prevention of any disease." This indicates it's not a therapeutic device.
No
The device is explicitly stated to be for "facial stimulation" and "over-the-counter cosmetic use" for "personal beauty purposes," and "not for use in any therapy for the treatment, or prevention of any disease." These statements indicate its purpose is cosmetic and not diagnostic.
No
The device description explicitly states it is a "non-invasive facial toning device" that "produces micro-current discharged through the dual probes." This indicates a physical hardware component that delivers electrical stimulation, not a software-only device. The performance studies also include electrical safety and electromagnetic compatibility testing, further confirming the presence of hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "facial stimulation" and "over-the-counter cosmetic use." IVDs are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not involve the examination of any biological specimens.
- Device Description: The description focuses on the device's function of producing micro-current for facial stimulation and toning. It explicitly states it 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 further reinforces its cosmetic, non-diagnostic purpose.
- Lack of IVD-related information: The document does not mention any aspects related to sample collection, analysis of biological markers, or diagnostic interpretation, which are core components of IVDs.
In summary, the Galvanic Spa (Model: SKB-1405) is a cosmetic device for facial stimulation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
NFO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
face
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use (21 CFR 801 Subpart C)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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
1
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 (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) 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: 0755-27697523 �
- Fax: 0755-27697514 �
- Contact Person (including title): Kimi xue �
- E-mail: sales06@siken3d.com �
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 |
4
| 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
Requiring
Biocompatibility | Material of
Component | Body Contact
Category
(ISO 10993-1) | Contact Duration
(ISO 10993-1) |
|------------------------------------------------------|--------------------------|-------------------------------------------|-----------------------------------|
| Electrodes | Stainless steel | Surface-contacting
device: skin | Maximum 2 hours
(