NUFACE MINI DEVICE

K133823 · Carol Cole Company · NFO · Apr 17, 2014 · Neurology

Device Facts

• Record ID: K133823
• Device Name: NUFACE MINI DEVICE
• Applicant: Carol Cole Company
• Product Code: NFO · Neurology
• Decision Date: Apr 17, 2014
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NuFACE® Mini Device is intended for facial stimulation and is indicated for overthe-counter cosmetic use. (21 CFR 801 Subpart C). The anatomical site for application of the NuFACE® Mini Device is the face.

Device Story

NuFACE® Mini is a non-invasive, at-home, over-the-counter facial toning device. It uses dual chrome-plated electrode spheres to deliver low-level microcurrent electrical impulses to facial skin and muscles. The device is operated by the user via a single control button to toggle power and adjust intensity levels. It requires the application of a conductive gel or medium. The device provides audio feedback (beeps) to cue the user to relocate the device every 5 seconds and to indicate power status. It is powered by internal rechargeable NiMH batteries, charged via an external DC power supply. The device is designed to increase facial contour and firm skin/muscles. It is a smaller, simplified version of the predicate NuFACE® Trinity, lacking interchangeable heads and a charging cradle.

Clinical Evidence

Bench testing only. No clinical data was provided. Substantial equivalence was established through comparative non-clinical performance testing of electrical output specifications, including waveform type, shape, voltage, current, frequency, and pulse characteristics, against the predicate device.

Technological Characteristics

Non-invasive, handheld facial toning device. Materials: thermoplastic resin housing, chrome-plated electrode spheres. Energy: internal rechargeable NiMH batteries, external DC power supply. Output: pulsed monophasic, modulated square waveform, microcurrent (millionths of an ampere). Connectivity: none. Software: microprocessor-controlled for output regulation, timing, and user feedback (beeps/LEDs). Standards: IEC 60601-1 (Electrical Safety), IEC 60601-1-2 (EMC), 21 CFR 898.

Indications for Use

Indicated for over-the-counter cosmetic facial stimulation for skin toning.

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

• NuFACE® Trinity (cleared as NuFACE® Plus) (K103472)

Submission Summary (Full Text)

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### 510(k) Summary NuFACE® Mini Device

#### CONTACT INFORMATION

Rand Daoud. Compliance Specialist Carol Cole Company 1325 Sycamore Ave, Suite A Vista, California 92081

Phone: [phone] x126 Facsimile: [phone] Email: [e-mail]

#### DEVICE NAME

Trade Name: NuFACE® Mini Device Common Name: Facial Toning Device Classification Name: Transcutaneous Electrical Nerve Stimulator (21 CFR 882.5890) Product Code: NFO

#### PREDICATE DEVICE

The Carol Cole Company is claiming substantial equivalence with its own device, the NuFACE® Trinity device, cleared as the NuFACE® Plus under 510(k) K103472. This Abbreviated 510(k) submission is a new design based on the manufacturer's cleared device. The electrical output of the NuFACE® Mini is identical to the previously cleared NuFACE® Trinity Facial Toning Device. Both devices are for transcutaneous electrical nerve stimulation for cosmetic use.

#### INDICATIONS FOR USE/INTENDED USE

The NuFACE® Mini Device is intended for facial stimulation and is indicated for overthe-counter cosmetic use. (21 CFR 801 Subpart C).

The anatomical site for application of the NuFACE® Mini Device is the face.

#### TECHNOLOGICAL CHARACTERISTICS

The NuFACE® Mini Device is a non-invasive at home, over-the-counter facial toning device. The dual spheres of the NuFACE® Mini Device are designed for optimal contact with the face and are identical in size to the predicate device. The NuFACE® Mini Device is extremely responsive as it delivers soft wave micro-current in the millionths of an ampere and has the ability to increase facial contour and firm the skin and muscles.

The NuFACE® Mini device measures 2.5" W x 4.2" L x 1.2" D. Its outer case is injection molded of thermoplastic resin. The device comes with an external Power Supply to charge the internal batteries of the device when not in use. The external Power Supply provides DC power from a pre-approved wall adapter. All charging circuitry is contained within the device itself. The microcurrent output is disabled when the device is connected to the external Power Supply.

An ascending sequence of beeps informs the customer the NuFACE® Mini is ready for use. When the user turns the device OFF, a descending tone is emitted. A

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single control button is used to turn the device on and off and to change the device's output intensity. A long press of the control button toggles the device between on and off.

To promote proper use, a single audio beep informs the user to relocate the device to treat a new location on the skin. The user can also adjust the output intensity by briefly pressing the control button to step between multiple micro-current output level selections. When the device is set to the maximum output and the control button is pressed, the device sequences to the minimum output.

#### COMPLIANCE DATA

The NuFACE® Mini Device is in conformance to the FDA's performance Standards set forth in 21 CFR §898. Additionally, there are no electrode lead wires or patient cables with this device.

The NuFACE® Mini Device will be tested for compliance with IEC 60601-1-2:2010 for radiated and power line conducted emissions and IEC 60601-1:2005 (3rd edition) for Electrical Safety.

## SUBSTANTIAL EQUIVALENCE

The NuFACE® Mini device has the same intended use and indications for use as the predicate device. The device also has nearly identical technological characteristics. During design and development, a Risk Analysis of the device was used to identify potential Hazards that could occur in use of the device, or in the event of Failure Modes of device components. The Risk Analysis was used to identify risk reduction measures which have been incorporated in the device design and labeling.

The determination of substantial equivalence for the NuFACE® Mini is based on an assessment of non-clinical performance. This assessment included a comparison of the output of the NuFACE® Mini to that of the predicate. The output performance testing included:

- 1. Waveform Type
- 2. Waveform Shape
- 3. Maximum Output Voltage
- 4. Maximum Output Current
- 5. Output Tolerance
- 6. Pulse Width

.

- 7. Output Frequency
- 8. Maximum Phase Charge
- 9. Maximum Current Density
- 10. Maximum Power Density
- 11. Burst Mode (i.e., pulse trains)
- a. Pulses per burst
- b. Pulses per second
- Burst duration C.
- d. Duty Cycle
- 12. ON Time

The results are provided in Section 3 (Output Specifications) below. As shown in the Substantial Equivalence Comparison Table:

- 1. Waveform type is identical to the predicate

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Waveform Shape is identical to the predicate 2.

3. Maximum Output Voltage is identical to the predicate

4. Maximum Output Current is identical to the predicate

- 5. Output Tolerance is identical to the predicate
- 6. Pulse Width is identical to the predicate
- 7. Output Frequency is identical to the predicate
- 8. Maximum Phase Charge is identical to the predicate
- 9. Maximum Current Density is identical to the predicate
- 10. Maximum Power Density is identical to the predicate
- 11. Burst Mode (i.e., pulse trains)
- a. Pulses per burst is identical to the predicate
- Pulses per second is identical to the predicate ﻓ
- Burst duration is identical to the predicate C.
- ರ. Duty Cycle is identical to the predicate

12. ON Time is identical to the predicate

The main body of the NuFACE® Mini Device is smaller in size than the predicate; however the functionality remains the same. The NuFACE® Mini does not use a charging cradle, but instead is charged from DC power supplied by an external power supply. The interchangeable head feature of the predicate NuFACE® Trinity device has also been eliminated on the NuFACE® Mini Device. The NuFACE® Mini Device will only function as a microcurrent emitting device.

The results support a determination of substantial equivalence in that the NuFACE® Mini provides the same functionality and microcurrent output as the predicate.

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## Section 1: Device Descriptions

| Section 1: Device<br>Descriptions | NuFACE® Mini<br>New Device | NuFACE® Trinity<br>(Cleared as the NuFACE® Plus)<br>Predicate Device |
|---------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. 510(k) Number | K133823 | K103472 |
| 2. Regulation<br>Number | 21 C.F.R. § 882.5890 | 21 C.F.R. § 882.5890 |
| 3. Regulation Name | Transcutaneous Electrical Nerve Stimulator | Transcutaneous Electrical Nerve Stimulator |
| 4. Regulatory Class | Class II | Class II |
| 5. Product Code | NFO | NFO |
| 6. Intended Use | Stimulate the face; skin toning | Stimulate the face; skin toning |
| 7. Indications for<br>Use | Over-the-Counter Cosmetic Use | Over-the-Counter Cosmetic Use |
| 8. Technological<br>Characteristics | The NuFACE® Mini is a facial toning device. The<br>chrome plated dual electrode spheres of the<br>NuFACE® Mini are designed to gently glide over<br>the skin to deliver low-level electrical impulses to<br>strategic locations on the face. The NuFACE®<br>Mini electrodes are designed for optimal contact<br>with the face.<br><br>The NuFACE® Mini microcurrent continually<br>alternates between the positive and negative<br>electrodes, and allows the user to adjust settings<br>for a personalized comfort level.<br><br>The outer case of the NuFACE® Mini is injection<br>molded of thermoplastic resin. The device comes<br>with an external Power Supply to charge the<br>internal batteries of the device, when the device is<br>not in use. The external Power Supply is a pre-<br>approved wall adapter. All charging circuitry is<br>contained within the device itself.<br><br>To turn the device on, the control button is<br>pressed. An ascending sequence of beeps and one<br>to five LED lights illuminate indicating the unit is<br>ready for use. Users then follow the instructions<br>for use. The NuFACE® Mini Device requires the<br>use of a conductive gel or medium during<br>treatment. The user can also adjust the output<br>level by briefly pressing the control button to shift<br>between multiple microcurrent output levels.<br>When the device is set to the maximum output and<br>the control button is pressed, the device sequences<br>to the minimum output. A long press of this<br>button toggles the device on and off.<br><br>To promote proper use and feedback to the user,<br>the NuFACE® Mini beeps to cue the user to<br>relocate the device after approximately 5 seconds<br>of treatment. When the user turns off the device.<br>a descending tone is emitted. | The NuFACE® Plus is a facial toning device.<br>Its outer case is injection molded<br>thermoplastic resin. The output contacts<br>(probes) consist of chrome-plated spheres.<br>The device, powered by four rechargeable AA<br>nickel-metal hydride batteries, produces a<br>micro-current that is discharged through the<br>two fixed, smooth spherical probes. To turn<br>the device on, the on/off button is pressed. An<br>ascending tone sounds, indicating the device<br>on. One to five red LED lights illuminate<br>indicating the unit is ready for use. Users then<br>follow the instructions for use. The two<br>probes gently glide over the skin to deliver<br>low-level electrical impulses to strategic<br>locations on the face. The NuFACE® Plus<br>probes are designed for optimal contact with<br>the face. The NuFACE® Plus micro-current<br>continually alternates between the positive and<br>negative probes, and allows the user to adjust<br>settings for a personalized comfort level. The<br>NuFACE® Plus device requires the use of a<br>conductive solution or gel. To promote proper<br>use and feedback to the user, the NuFACE®<br>Plus beeps to cue the user to relocate the<br>device approximately every 5 seconds. The<br>beep also informs the user that the two spheres<br>are making contact with the skin surface. An<br>alert tone sounds to indicate that both probes<br>are not touching the skin during treatment. |
| Section 2: Basic Unit<br>Characteristics | NuFACE® Mini Device<br>New Device | NuFACE® Trinity<br>(Cleared as the NuFACE® Plus)<br>- Predicate Device |
| 1. 510(k) Number | K133823 | K103472 |
| 2. Device Name, Model | NuFACE® Mini Device | NuFACE® Trinity |
| 3. Manufacturer | Carol Cole Company (CCC) | Carol Cole Company (CCC) |
| 4. Power Source(s) | | |
| a. Method of Line Current<br>Isolation | 2 rechargeable AA NiMH<br>batteries | 4 rechargeable AA NiMH batteries |
| b. Patient Leakage Current | | |
| 1. Normal condition | N/A - Battery Operated | N/A - Battery Operated |
| 2. Single fault condition | N/A - Battery Operated | N/A - Battery Operated |
| 5. Number of Output Modules | 1 | 1 |
| 6. Number of Output Channels | 1 | 1 |
| a. Synchronous or Alternating | N/A - 1 Output Channel | N/A - 1 Output Channel |
| b. Method of Channel Isolation | N/A - 1 Output Channel | N/A - 1 Output Channel…