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.

AI/ML Overview

This document is a 510(k) premarket notification for the NuFACE Mini Plus, a cosmetic device. It focuses on demonstrating substantial equivalence to a predicate device (NuFACE Mini) rather than presenting a clinical study to prove the device meets acceptance criteria for a medical diagnosis or treatment.

Therefore, many of the requested details, such as sample size for test/training sets, expert qualifications, ground truth establishment methods (for medical conditions), MRMC studies, or effect sizes for human readers, are not applicable to the information provided in this regulatory submission.

The document primarily addresses non-clinical performance data to show that the new device is as safe and effective as the predicate device, not that it meets specific diagnostic or treatment accuracy acceptance criteria as one might expect for an AI-enabled diagnostic device.

Here's a breakdown of the available information based on your request, explaining why certain points are not present:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a typical "acceptance criteria" table in the sense of diagnostic accuracy (e.g., sensitivity, specificity, AUC) against clinical ground truth. Instead, it compares the technical specifications and safety/performance testing results of the subject device (NuFACE Mini Plus) to its predicate device (NuFACE Mini) to demonstrate substantial equivalence.

Here's a table summarizing the primary comparisons, which serve as the "performance" demonstrated for this type of device submission:

Item	Acceptance/Comparison Point	Subject Device (NuFACE Mini Plus) Reported Performance	Predicate Device (NuFACE Mini) Performance	Meets Equivalence?
Intended Use	Identical Indications	Facial and neck stimulation for over-the-counter cosmetic use.	Facial and neck stimulation for over-the-counter cosmetic use.	Yes (Identical)
Type of Energy Output	Microcurrent	Microcurrent	Microcurrent	Yes (Same)
Energy Delivery	Plated dual sphere electrodes	Plated dual sphere electrodes	Plated dual sphere electrodes	Yes (Same)
Energy Flow	Alternating between positive/negative electrodes	Microcurrent continuously alternates between the positive and negative electrode spheres	Microcurrent continuously alternates between the positive and negative electrode spheres	Yes (Same)
Energy Output	User adjustable	User adjustable	User adjustable	Yes (Same)
Energy Power Source	Internal rechargeable battery	Internal rechargeable battery	Internal rechargeable battery	Yes (Same)
Battery Type	Lithium Ion	Lithium Ion	Lithium Ion	Yes (Same)
Charging Circuitry	Internal to Device	Internal to Device	Internal to Device	Yes (Same)
Power Supply Type	Pre-approved wall-mount Power Adaptor	Pre-approved wall-mount Power Adaptor	Pre-approved wall-mount Power Adaptor	Yes (Same)
Special Requirements	Conductive Gel Primer	Conductive Gel Primer	Conductive Gel Primer	Yes (Same)
Waveform Type	Pulsed Biphasic	Pulsed Biphasic	Pulsed Biphasic	Yes (Same)
Shape	Modulated Square	Modulated Square	Modulated Square	Yes (Same)
Maximum Output Voltage	28 VDC	28 VDC	28 VDC	Yes (Same)
Maximum Output Current	335 µA	348 µA	Yes (Within Acceptable Range)
Maximum Output Current Density	0.435 mA/cm²	0.452 mA/cm²	Yes (Within Acceptable Range)
Microcurrent Output (Device OFF/Charging)	< 10 µA	< 1 µA	Yes (Both are low/safe)
Output Tolerance	+/- 5% (RMS)	+/- 5% (RMS)	Yes (Same)
Beat Frequency	No Beat Frequency	No Beat Frequency	Yes (Same)
Symmetrical Phases	Not Multiphasic	Not Multiphasic	Yes (Same)
Phase Duration	Not Multiphasic	Not Multiphasic	Yes (Same)
Net Charge (per pulse)	N/A - Battery operated	N/A - Battery operated	Yes (Same)
Pulses Per Burst	20 (10 positive and 10 negative)	20 (10 positive and 10 negative)	Yes (Same)
Duty Cycle (DC)	50%	50%	Yes (Same)
Output Current Range	70 to 335 µA	35 to 348 µA	Yes (Comparable Range)
Default Treatment Frequency	Approximately 8.3 Hz	Approximately 8.3 Hz	Yes (Same)
Electrical Safety	Compliance with applicable Standards	Compliant	Compliant (Likely, as predicate was cleared)	Yes
EMC	Compliance with applicable Standards	Compliant	Compliant (Likely, as predicate was cleared)	Yes
Performance Bench Testing	Meets performance specifications	The NūFACE® Mini Plus meets its performance specifications and is substantially equivalent to the predicate device performance.	Meets its performance specifications	Yes
Software V&V	Requirements met, risk mitigations implemented, conforms to user needs/intended uses	All requirements/specifications implemented, risk mitigations implemented, conforms to user needs and intended uses.	N/A (New software functionality for BLE)	Yes

Differences and Justification:

Output Frequency (Hz): Subject device (Variable: 0.3 - 50 Hz) vs. Predicate (Fixed: Approximately 8.3 Hz). This is a difference, but likely justified through safety testing and remaining within general microcurrent parameters.
Wireless Technologies: Subject device has Bluetooth Low Energy (BLE) vs. Predicate (None). This is a new feature, addressed by software verification and wireless coexistence testing.
Pulse Period (Pulse Width): Subject device (Varies with Output Frequency) vs. Predicate (60 msec). Related to the variable frequency.
Output Frequency (Hz): Subject device (0.3 - 50 Hz (Variable)) vs. Predicate (Approximately 8.3 Hz). Explained above.
Microcurrent Output (Device OFF / Not Stimulating): Subject device (< 10 µA) vs. Predicate (< 1 µA). Both are very low and considered safe for an "off" state.
Pulses Per Second: Subject device (Variable) vs. Predicate (8.3). Related to the variable frequency.
Burst Duration (sec): Subject device (Variable) vs. Predicate (2.4 sec). Related to the variable frequency.

The document argues that these differences do not raise new questions of safety or effectiveness.

2. Sample Size Used for the Test Set and the Data Provenance:

Test Set (for performance comparison): Not applicable in the context of clinical data for diagnostic performance. The "test set" here refers to the actual subject device undergoing various non-clinical engineering and safety tests.
Data Provenance: The tests are conducted internally by the manufacturer or by third-party testing labs. No information on country of origin for the data is provided, as it's not a clinical data set. The tests are "prospective" in the sense that they were performed specifically for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. This device does not generate a diagnostic output requiring expert interpretation for ground truth. Ground truth for engineering tests is established by calibrated measurement devices and compliance with industry standards.

4. Adjudication Method for the Test Set:

Not applicable. There's no human interpretation or subjective assessment of outcomes that would require adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is not an AI-enabled diagnostic imaging device or one that involves human readers interpreting results.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance:

Not applicable in the typical sense of an algorithm making a medical diagnosis. The device's "performance" is its ability to generate microcurrent within specified parameters safely, as measured by bench testing. The software component, which controls the device, undergoes verification and validation to ensure it operates correctly according to its specifications.

7. The Type of Ground Truth Used:

For Biocompatibility: Compliance with ISO 10993-1 categorization based on material type, contact, and duration, and prior FDA clearance of identical materials.
For Electrical Safety/EMC: Compliance with applicable (IEC) standards, measured using calibrated test equipment.
For Performance Bench Testing: Measured electrical outputs (voltage, current, frequency, etc.) compared to internal design specifications and the predicate device's specifications, using calibrated test equipment.
For Software Verification and Validation: Software requirements, design specifications, and risk mitigations (i.e., whether the software behaves as intended and safely).

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. See point 8.

Summary

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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

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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

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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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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 AVista, 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 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 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 EnergyOutput	Microcurrent	Microcurrent	Same
Energy Delivery	Microcurrent is delivered viaplated dual sphere electrodes(optimized for contact with theskin)	Microcurrent is delivered viaplated dual sphere electrodes(optimized for contact with theskin)	Same

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Item	Subject Device	Predicate Device	Same /Different
Energy Flow	Microcurrent continuously alternates between the positive and negative electrode spheres	Microcurrent continuouslyalternates between the positiveand negative electrode spheres	Same
Energy Output	User adjustable	User adjustable	Same
Energy PowerSource	Internal rechargeable battery	Internal rechargeable battery	Same
Battery Type	Lithium Ion	Lithium Ion	Same
ChargingCircuitry	Internal to Device	Internal to Device	Same
Power SupplyType	Pre-approved wall-mount Power Adaptor	Pre-approved wall-mount PowerAdaptor	Same
SpecialRequirements	Conductive Gel Primer	Conductive Gel Primer	Same
OutputFrequency (Hz)	Variable	Fixed	Different
WirelessTechnologies	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 DeviceSpecification	Predicate DeviceSpecification	Same /Different
Waveform Type	Pulsed Biphasic	Pulsed Biphasic	Same
Shape (e.g., rectangular, spike)	Modulated Square	Modulated Square	Same
Maximum OutputVoltage	28 VDC	28 VDC	Same
Maximum OutputCurrent	335 μA	348 μA	Same
Maximum OutputCurrent Density	0.435 mA/cm²	0.452 mA/cm²	Same
Item	Subject DeviceSpecification	Predicate DeviceSpecification	Same /Different
MicrocurrentOutput (DeviceOFF / NotStimulating	< 10 μ Α(device is OFF or Chargingthe battery)	< 1 µA(device is OFF or Chargingthe battery)	Different
Output Tolerance	+/- 5% (RMS)	+/- 5% (RMS)	Same
Pulse Period(Pulse Width)	Varies with OutputFrequency	60 msec	Different
Output Frequency(Hz)	0.3 - 50 Hz (Variable)	Approximately 8.3 Hz	Different
Beat Frequency(Hz)	No Beat Frequency	No Beat Frequency	Same
SymmetricalPhases	Not Multiphasic	Not Multiphasic	Same
Phase Duration	Not Multiphasic	Not Multiphasic	Same
Net Charge (μCper pulse)	N/A - Battery operated	N/A - Battery operated	Same
Pulses Per Burst	20 (10 positive and 10negative)	20 (10 positive and 10negative)	Same
Pulses Per Second	Variable	8.3	Different
Burst Duration(sec)	Variable	2.4 sec	Different
Duty Cycle (DC)	50%	50%	Same
ON Time (msec)	Variable	60	Different
OFF Time (msec)	Variable	60	Different
Output CurrentRange	70 to 335 µA	35 to 348 μ A	Same
Default TreatmentFrequency (Hz)	Approximately 8.3 Hz	Approximately 8.3 Hz	Same

Table 2: Performance Specifications Comparison

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7. Non-Clinical Performance Data

A program of non-clinical verification and validation testing was conducted that includes:

. Biocompatibility
Electrical Safety, EMC, and Performance Testing .
Software Verification and Validation Testing

CONFIDENTIAL NūFACE®

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7.1. Biocompatibility

Table 3 the conclusions drawn for each type of material used in the construction of the subject device and the accessories included with it. The metal and thermoplastic materials used in the NuFACE® Mini Plus are identical to materials already used in FDA-cleared devices in formulation, processing, sterilization, and geometry, and no other chemicals have been added. Biocompatibility is addressed in detail in a separate document in this premarket submission.

Material	Where Used(Subject Device)	Categorization(ISO 10993-1)	Conclusion
Metal	· Spheres.	Surface device, intactskin, limited contactduration (<24h).	Biocompatible.These materials are usedin other FDA-cleareddevices.
Thermoplastic	· Device Enclosure.· Grip Over-Mold.· Wall-Mount Power supply.	Surface device, intactskin, limited contactduration (<24h).	Biocompatible.These materials are usedin other FDA-cleareddevices.
MoisturizingGel	• Conductivity Gel Primer.	Surface device, intactskin, limited contactduration (<24h).	Biocompatible.These materials are usedin other FDA-cleareddevices.

Table 3: NuFACE® Mini Plus Materials Biocompatibility

7.2. Electrical Safety, EMC, and Performance Testing

The following conclusions were drawn from the conducted Safety, Performance and Bench Testing:

1. Electrical Safety testing results demonstrated that the NuFACE® Mini Plus is compliant with applicable Standards for Electrical Safety.
1. Electromagnetic Compatibility (EMC) testing results demonstrated that the NuFACE® Mini Plus is compliant with applicable Standards for Electromagnetic Compatibility and Wireless Coexistence.
1. Performance Bench testing results demonstrated that the NūFACE® Mini Plus meets its performance specifications and is substantially equivalent to the predicate device performance.

7.3. Software Verification and Validation Testing

Software Verification and Validation Testing results demonstrated that:

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.

CONFIDENTIAL NūFACE®

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7.4. Animal Testing

The substantial equivalence for the subject device is not supported by animal testing. Therefore, no animal testing was conducted.

7.5. Clinical Testing

The substantial equivalence for the subject device is not demonstrated by results of clinical testing. Therefore, no clinical testing were performed.

8. Overall Conclusion

The documentation and test results provided in this submission and comparison of intended use, principle of operation, performance data, design and the overall technological characteristics, demonstrate that the NuFACE® Mini Plus is as safe, as effective, and performs as well as the predicate device.

Regulation Number and Section

§ 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).