NUFACE PLUS

K103472 · Carol Cole Company · NFO · Nov 7, 2011 · Neurology

Device Facts

• Record ID: K103472
• Device Name: NUFACE PLUS
• Applicant: Carol Cole Company
• Product Code: NFO · Neurology
• Decision Date: Nov 7, 2011
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

NüFACE® Plus is a handheld facial toning device for over-the-counter cosmetic use. It delivers low-level microcurrent (80–400 µA) via two chrome-plated spherical probes. The device requires a conductive gel for operation. Users glide the probes over facial skin to deliver electrical impulses; the device alternates current between probes. Integrated microprocessor control provides user feedback: an ascending tone indicates readiness; a single beep cues the user to relocate the device every 5 seconds; an alert tone sounds if probes lose skin contact. The device features a 21-minute timer and adjustable intensity settings. Output is powered by four rechargeable NiMH batteries. The device is intended to increase facial contour and firm skin/muscles. Healthcare providers do not operate the device; it is for patient self-use.

Clinical Evidence

No clinical data. Bench testing only, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and performance standards (21 CFR 898).

Technological Characteristics

Handheld facial toning device; injection-molded thermoplastic resin housing; chrome-plated spherical probes. Energy source: 4 rechargeable NiMH batteries. Output: Pulsed monophasic, modulated square waveform; 8.40 Hz frequency; 80-400 µA current. Microprocessor-controlled with timer, automatic no-load trip, and automatic shut-off. Connectivity: None. Sterilization: Not applicable (non-sterile).

Indications for Use

Indicated for over-the-counter cosmetic facial stimulation/toning in adults.

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® (K072260)

Submission Summary (Full Text)

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K103472

NOV - 7 2011

## Abbreviated 510(k) Summary NüFACE® Plus Device

#### Prepared: November 11, 2010, updated December 22, 2010

#### CONTACT INFORMATION

Carol Cole Company 3146 Tiger Run Court; Suite 109 Carlsbad. California 92010

Phone: [phone] Facsimile: [phone] Email: [e-mail] Contact Person: Tera Valdez, Vice President

#### DEVICE NAME

Trade Name: NūFACE® Plus 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 NiFACE® device, cleared under K072260. This Abbreviated 510(k) submission is a new design based on the manufacturer's cleared device. Both devices are for transcutaneous electrical nerve stimulation for cosmetic use.

## INDICATIONS FOR USE/INTENDED USE

The NüFACE® Plus Facial Toning Device is intended for facial stimulation and is indicated for over-the-counter cosmetic use. (21 CFR 801 Subpart C).

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

## TECHNOLOGICAL CHARACTERISTICS

NūFace® Plus is a Facial Toning Device intended for facial stimulation. It produces microcurrent discharged through the two spherical probes. Microcurrent 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 80 - 400 µA.

The device measures 3" W x 5.25" L x 1.25" D. Its outer case is injection molded of thermoplastic resin and the output contacts (probes) consist of chrome-plated spheres. The device is powered by 4 rechargeable batteries. The NūFACE® Plus comes with a rechargeable base, which measures 3.25" W x 4" L x 3.25" D.

To turn the device on, an ON/OFF button is pressed. Users then follow the instructions for use. The two probes gently glide over the skin to deliver low-level electrical impulses to strategic locations on the face.

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The NūFACE® Plus probes are designed for optimal contact with the face. The NūFACE® Plus device continually alternates between the positive and negative probes, and allows the user to adjust settings from 0 to 400 microamps for a personalized comfort level. The NiFACE® Plus device requires the use of a conductive gel.

An ascending sequence of beeps informs the customer the NūFACE® Plus is ready for use. When the user turns off the device, a descending tone is emitted.

To promote proper use three alert beeps will sound if both probes are not touching the skin during treatment. Also to promote proper use, a single audio beep informs the user to relocate the device to treat a new location on the skin. User can also adjust output by pressing the + or - intensity buttons to increase or decrease microcurrent.

## COMPLIANCE DATA

The NūFace® Plus Facial Toning Device was tested and found to be in compliance with FDA's performance standards set forth in 21 CFR §898.

The NuFace® Plus device was also tested and found to be in compliance with IEC 60601-1-2 for radiated and power line conducted emissions. The NūFace® Plus device was evaluated and found to be in compliance with IEC 60601-1 for Electrical Safety.

#### SUBSTANTIAL EQUIVALENCE

The NūFACE® Plus device has the same intended use and indications for use as the predicate device. The device also has similar 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.

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## Section 1: Device Descriptions

| Section 1: Device Descriptions | NuFACE® Plus<br>New Device | NuFace® Original<br>Predicate Device |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. 510(k) Number | To Be Assigned | K072260 |
| 2. Regulation 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 Use | Over-the-Counter Cosmetic Use | Over-the-Counter Cosmetic Use |
| 8. Technological Characteristics | The NuFACE® Plus is a facial toning device. Its<br>outer case is injection molded thermoplastic resin.<br>The output contacts (probes) consist of chrome-plated<br>spheres. The device, powered by four rechargeable<br>AA nickel-metal hydride batteries, produces a micro-<br>current that is discharged through the two fixed,<br>smooth spherical probes. To turn the device on, the<br>on/off button is pressed. An ascending tone sounds,<br>indicating the device on. One to five red LED lights<br>illuminate indicating the unit is ready for use. Users<br>then follow the instructions for use. The two probes<br>gently glide over the skin to deliver low-level<br>electrical impulses to strategic locations on the face.<br>The NuFACE® Plus probes are designed for optimal<br>contact with the face. The NuFACE® Plus micro-<br>current continually alternates between the positive<br>and 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 use<br>and feedback to the user, the NuFACE® Plus beeps<br>to cue the user to relocate the device approximately<br>every 5 seconds. The beep also informs the user that<br>the two spheres are making contact with the skin<br>surface. An alert tone sounds to indicate that both<br>probes are not touching the skin during treatment. | NuFace® is a facial toning device. Its outer case is<br>injection molded thermoplastic resin, and the output<br>contacts (probes) consist of chrome-plated spheres.<br>The device, powered by a 9-volt battery, produces a<br>micro-current that is discharged through the two fixed,<br>smooth spherical probes. To turn the device on, the<br>thumbwheel is pushed upwards. A Green LED light<br>will then illuminate, indicating the unit is ready for use.<br>Users then follow the instructions for use. The two<br>probes gently glide over the skin to deliver low-level<br>electrical impulses to strategic locations on the face.<br>The NuFace® probes are designed for optimal contact<br>with the face. The NuFace® device micro-current<br>continually alternates between the positive and<br>negative probes, and allows the user to adjust settings<br>for a personalized comfort level. The NuFace® device<br>requires the use of a conductive solution or gel. |
| | | |

#### Device Descriptions NuFACE® Plus and Original NuFace® Device Comparison Table

Carol Cole Company NuFACE® Plus : 510(k) Summary - updated 1/13/2011

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## Section 2: Basic Unit Characteristics

NuFACE® Plus and Original NuFace® Device Substantial Equivalence Comparison Table

.

| Section 2: Basic Unit Characteristics | NuFACE® Plus<br>New Device | NuFace® Original<br>Predicate Device |
|-------------------------------------------------|------------------------------------|--------------------------------------|
| 1. 510(k) Number | To be assigned | K072260 |
| 2. Device Name, Model | NuFACE® Plus | NuFace® |
| 3. Manufacturer | Carol Cole Company (CCC) | Carol Cole Company |
| 4. Power Source(s) | | |
| a. Method of Line Current Isolation | 4 rechargeable AA NiMH batteries | One 9V Battery |
| 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 - I Output Channel | N/A - 1 Output Channel |
| b. Method of Channel Isolation | N/A - 1 Output Channel | N/A - 1 Output Channel |
| 7. Regulated Current or Regulated Voltage? | Both | Both |
| 8. Software/Firmware/Microprocessor Control? | Yes | No |
| 9. Automatic Overload Trip? | Not required due to circuit design | No |
| 10. Automatic No-Load Trip? | Yes | No |
| 11. Automatic Shut Off? | Yes | No |
| 12. Patient Override Control? | Yes | Yes |
| 13. Indicator Display | | |
| a. On/Off Status? | Yes | Yes |
| b. Low Battery? | Yes | No |
| c. Voltage/Current Level? | Yes | No |
| 14. Timer Range (minutes) | Yes (21 minutes) | N/A - No Timer |
| 15. Compliance with Voluntary Standards? | EN 60601-1-2 | EN 60601-1 |
| 16. Compliance with 21 CFR 898? | Yes | Yes |
| 17. Weight | 9 oz without charging base | 0.5 lbs |
| 18. Dimensions of device(inch) [ W x L x D] | 3" x 5.25" x 1.25" | 2.25" x 7" x 0.75" |
| 19. Dimensions of charging Unit (inch) [W x L x | 3.25" x 4" x 3.25" | NA |
| 19. Housing Materials and Construction | Thermo Plastic | Thermo Plastic |

. .

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# Section 3: Output Specifications

| Output Specifications | |
|-----------------------------------------------------------------------------------|--|
| NuFACE® Plus and Original NuFace® Device Substantial Equivalence Comparison Table | |

| Section 3: Output Specifications | NuFACE® Plus<br>New Device | NuFace® Original<br>Predicate Device |
|--------------------------------------------------------|----------------------------|--------------------------------------|
| Waveform (e.g., pulsed monophasic, biphasic) | Pulsed MonoPhasic | Pulsed MonoPhasic |
| Shape (e.g., rectangular, spike, rectified sinusoidal) | Modulated Square | Modulated Square |
| Maximum Output Voltage (specify units) | 137 mV @ 500 Ω | 158 mV @ 500 Ω |
| | 769 mV @ 2 kΩ | 780 mV @ 2 kΩ |
| | 3.82 V @ 10 kΩ | 2.6 V @ 10 kΩ |
| Maximum Output Current (specify units) | 274 μA @ 500 Ω | 223 μA @ 500 Ω |
| | 387 μA @ 2 kΩ | 358 μA @ 2 kΩ |
| | 383 μA @ 10 kΩ | 263 μA @ 10 kΩ |
| Output Tolerance | +/- 2% | +/- 10% |
| Pulse Width (specify units) | 119 ms | 112 ms |
| Frequency (Hz) | 8.40 Hz | 8.39 Hz |
| For interferential modes only | | |
| Beat Frequency (Hz) | No Beat Frequency | No Beat Frequency |
| For multiphasic waveforms only | | |
| Symmetrical phases? | Not Multiphasic | Not Multiphasic |
| Phase Duration (include units) | Not Determined | Not Determined |
| Net Charge (µC per pulse) | N/A - Battery Operated | N/A - Battery Operated |
| Maximum Phase Charge (µC) | 23.06 µC @ 500 Ω | 18.13 µC @ 500 Ω |
| Maximum Current Density (mA/cm²) | 0.419 mA/cm² @ 500 Ω | 0.341 mA/cm² @ 500 Ω |
| Maximum Power Density (µW/cm²) | 3.22 µW/cm² @ 500 Ω | 3.02 µW/cm² @ 500 Ω |
| Burst Mode (i.e., pulse trains) | | |
| Pulses per burst | 20 | 21 |
| b. Pulses per second | 8.4 | 9.1 |
| c. Burst duration (seconds) | 2.4 | 2.3 |
| d. Duty Cycle [Line (b) x Line (c)] | 20.2 | 20.9 |
| ON Time (seconds) | Constant | Constant |
| OFF Time (seconds) | None | None |

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Image /page/5/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three branches of government. The eagle is surrounded by a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

#### Public Health Service

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

NOV - 7 2011

Carol Cole Company c/o Mr. Bob Duffy President Bob Duffy Associates, Inc. 16405 Summer Sage Road Poway, CA 92604

Re: K103472

Trade/Device Name: NuFace Plus Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NFO Dated: September 28, 2011 Received: October 3, 2011

Dear Mr. Duffy:

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.

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Page 2 - Mr. Bob Duffy

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia Alexander

for

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

## Abbreviated 510(k) for NuFACE® Plus Device

510(k) Number for original device to which Substantial Equivalence to a manufacturer's own device: K072260

Indications For Use:

The NuFACE® Plus Facial Toning Device is intended for facial stimulation and is indicated for over-the-counter cosmetic use (21 CFR 807 Subpart C).

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use _ X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Tine C. Rela

(Division Sign-Off) ----Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K103472

Carol Cole Company
Indications for Use