(242 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on microcurrent technology and user-controlled settings, with the app primarily for customization. There is no mention of algorithms learning from data or making decisions based on complex patterns.
No.
The intended use explicitly states "for over-the-counter cosmetic use," not for therapeutic medical purposes.
No
The device is intended for facial and neck stimulation for over-the-counter cosmetic use, not for diagnosing any medical conditions.
No
The device description clearly states it comprises the Mini Plus device itself and a wall-mount power adaptor, and produces microcurrent through physical spheres. This indicates a hardware component is central to its function, not just software. While it has a companion app, the core medical device is hardware.
Based on the provided information, the NuFACE® Mini Plus device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "facial and neck stimulation" for "over-the-counter cosmetic use." This clearly indicates a cosmetic purpose applied externally to the body.
- Device Description: The device applies microcurrent to the skin. This is a physical interaction with the body's surface, not an analysis of biological samples (like blood, urine, or tissue) which is the hallmark of IVDs.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, diagnosing conditions, or providing information about a person's health status based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. The NuFACE® Mini Plus does not fit this description.
N/A
Intended Use / Indications for Use
The NuFACE® Mini Plus device is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use.
Product codes
NFO
Device Description
The NuFACE® Mini Plus (subject device) comprises the Mini Plus device itself and a wall-mount power adaptor. A tube of NuFACE® Gel Primer is provided with the device as an accessory. The Instructions for Use (IFU) are also included with the device and all its associated components are reusable and provided non-sterile.
The subject device produces low levels of microcurrent that is discharged through two chrome-plated spheres when they come in contact with and are glided over the skin being treated.
The subject device allows the user to turn on and turn off the device at any time during the treatment. Once the device is on, the user can select different microcurrent intensity levels. The device provides visual (lights), audible (beeps) and haptic (hum) feedback to guide the user during treatment. The device will shut off automatically after 20 minutes of use.
The subject device is powered by one internal rechargeable, non-removable battery which is charged via the provided wall-mount power adaptor. During battery charging the device microcurrent output is disabled to prevent accidental and/or intentional use.
The subject device is capable of pairing and connecting to compatible smart devices using Bluetooth Low Energy (BLE) technology. BLE allows the subject device to wirelessly communicate with other devices such a smart phone running the NuFACE® App. The NuFACE® App allows the user to customize treatment options.
The subject device is made from thermoplastic and metal materials already used in other FDA-cleared medical devices. The device measures 2.7" W x 3.6" L x 2.6" D.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
facial and neck
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data:
- Biocompatibility: "Biocompatible. These materials are used in other FDA-cleared devices." for Metal, Thermoplastic, and Moisturizing Gel.
- Electrical Safety, EMC, and Performance Testing:
- "Electrical Safety testing results demonstrated that the NuFACE® Mini Plus is compliant with applicable Standards for Electrical Safety."
- "Electromagnetic Compatibility (EMC) testing results demonstrated that the NuFACE® Mini Plus is compliant with applicable Standards for Electromagnetic Compatibility and Wireless Coexistence."
- "Performance Bench testing results demonstrated that the NūFACE® Mini Plus meets its performance specifications and is substantially equivalent to the predicate device performance."
- Software Verification and Validation Testing:
- "All requirements and specifications in the NuFACE® Mini Plus Software Requirements Specification were implemented and operate correctly."
- "All Risk Mitigations to be implemented in software were implemented and operate correctly, and"
- "the software conforms with the user needs and intended uses of the NuFACE® Mini Plus device."
Animal Testing: Not performed.
Clinical Testing: Not performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 19, 2021
Carole Cole Company Bob Duffy Regulatory Affairs Senior Manager 1325 Sycamore Ave. Suite A Vista, California 92081
Re: K201680
Trade/Device Name: NuFACE Mini Plus Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NFO Dated: December 9, 2020 Received: December 10, 2020
Dear Bob Duffy:
We have reviewed vour 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, 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
1
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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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,
Heather Dean, PhD Assistant Director. Acute Iniury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201680
Device Name NuFACE Mini Plus
Indications for Use (Describe)
The NuFACE® Mini Plus device is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic 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
This 510(k) summary is being submitted in accordance with the requirements established by 21 CFR 807.92.
1. Submitter Information
| Submitter: | Carol Cole Company dba NūFACE |
|---|---|
| Address: | 1325 Sycamore Ave, Suite A |
| Vista, CA 92081 (USA) |
| Contact Person: | Tera Peterson |
|---|---|
| Chief Executive Officer | |
| Phone: (760) 509-1187 | |
| Email: tpeterson@myNuFACE.com |
Date Prepared: February 17, 2021
2. Subject Device
| 510(k) Premarket Notification: | K201680 |
|---|---|
| Device Trade / Proprietary Name: | NūFACE® Mini Plus |
| Device Common or Usual Name: | NūFACE® Mini Plus Facial and Neck Toning Device |
| Regulation Number: | 21 CFR 882.5890 |
| Classification Name: | Transcutaneous electrical nerve stimulator for pain relief |
| Product Code: | NFO |
| FDA Panel: | 84 - Neurology |
| Class: | II |
3. Predicate Device
Legally marketed predicate device to which the Carol Cole Company dba NūFACE is claiming substantial equivalence to:
| 510(k) Number: | K191672 |
|---|---|
| Manufacturer: | Carol Cole Company dba NūFACE |
| Trade Name: | NūFACE® Mini |
| Regulation Number: | 21 CFR 882.5890 |
| Classification Name: | Transcutaneous electrical nerve stimulator for pain relief |
| Product Code: | NFO |
| FDA Panel: | 84 - Neurology |
| Class: | II |
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4. Device Description
The NuFACE® Mini Plus (subject device) comprises the Mini Plus device itself and a wall-mount power adaptor. A tube of NuFACE® Gel Primer is provided with the device as an accessory. The Instructions for Use (IFU) are also included with the device and all its associated components are reusable and provided non-sterile.
The subject device produces low levels of microcurrent that is discharged through two chrome-plated spheres when they come in contact with and are glided over the skin being treated.
The subject device allows the user to turn on and turn off the device at any time during the treatment. Once the device is on, the user can select different microcurrent intensity levels. The device provides visual (lights), audible (beeps) and haptic (hum) feedback to guide the user during treatment. The device will shut off automatically after 20 minutes of use.
The subject device is powered by one internal rechargeable, non-removable battery which is charged via the provided wall-mount power adaptor. During battery charging the device microcurrent output is disabled to prevent accidental and/or intentional use.
The subject device is capable of pairing and connecting to compatible smart devices using Bluetooth Low Energy (BLE) technology. BLE allows the subject device to wirelessly communicate with other devices such a smart phone running the NuFACE® App. The NuFACE® App allows the user to customize treatment options.
The subject device is made from thermoplastic and metal materials already used in other FDA-cleared medical devices. The device measures 2.7" W x 3.6" L x 2.6" D.
4.1. Intended Use
The Indications for Use statement for the subject device is identical to the predicate device.
| Subject Device | Predicate device |
|---|---|
| The NūFACE® Mini Plus device is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use. | The NūFACE® Mini Device is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use. |
5. Technological Characteristics
Table 1provides a comparison between the technological characteristics of the NuFACE® Mini Plus and the predicate device.
| Table 1: Technological Characteristics | ||
|---|---|---|
| -- | -- | ---------------------------------------- |
| Item | Subject Device | Predicate Device | Same /
Different |
|--------------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|---------------------|
| Type of Energy
Output | Microcurrent | Microcurrent | Same |
| Energy Delivery | Microcurrent is delivered via
plated dual sphere electrodes
(optimized for contact with the
skin) | Microcurrent is delivered via
plated dual sphere electrodes
(optimized for contact with the
skin) | Same |
5
| Item | Subject Device | Predicate Device | Same /
Different |
|--------------------------|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|---------------------|
| Energy Flow | Microcurrent continuously alternates between the positive and negative electrode spheres | Microcurrent continuously
alternates between the positive
and negative electrode spheres | Same |
| Energy Output | User adjustable | User adjustable | Same |
| Energy Power
Source | Internal rechargeable battery | Internal rechargeable battery | Same |
| Battery Type | Lithium Ion | Lithium Ion | Same |
| Charging
Circuitry | Internal to Device | Internal to Device | Same |
| Power Supply
Type | Pre-approved wall-mount Power Adaptor | Pre-approved wall-mount Power
Adaptor | Same |
| Special
Requirements | Conductive Gel Primer | Conductive Gel Primer | Same |
| Output
Frequency (Hz) | Variable | Fixed | Different |
| Wireless
Technologies | Bluetooth Low Energy (BLE) | None | Different |
6. Performance Specifications Comparison
Table 2 provides a comparison between the performance specifications of the NuFACE® Mini Plus and the predicate device.
| Item | Subject Device
Specification | Predicate Device
Specification | Same /
Different |
|------------------------------------------------------------|--------------------------------------------------------|------------------------------------------------------|---------------------|
| Waveform Type | Pulsed Biphasic | Pulsed Biphasic | Same |
| Shape (e.g., rectangular, spike) | Modulated Square | Modulated Square | Same |
| Maximum Output
Voltage | 28 VDC | 28 VDC | Same |
| Maximum Output
Current | 335 μA | 348 μA | Same |
| Maximum Output
Current Density | 0.435 mA/cm² | 0.452 mA/cm² | Same |
| Item | Subject Device
Specification | Predicate Device
Specification | Same /
Different |
| Microcurrent
Output (Device
OFF / Not
Stimulating |