NuFACE Trinity

K181008 · Carol Cole Company Dba Nuface · NFO · Oct 11, 2018 · Neurology

Device Facts

• Record ID: K181008
• Device Name: NuFACE Trinity
• Applicant: Carol Cole Company Dba Nuface
• Product Code: NFO · Neurology
• Decision Date: Oct 11, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NuFACE Trinity is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use.

Device Story

NuFACE Trinity is a handheld, battery-operated device for facial and neck skin stimulation; intended for over-the-counter cosmetic use. Device utilizes two fixed, chrome-plated spherical probes to deliver low-level electrical impulses (microcurrent) to the skin. Operation requires application of a conductive gel; user glides spheres over target areas. Device features microprocessor control; provides audible beeps to cue user to relocate device every 5 seconds; includes LED indicators for intensity levels. Output is a constant biphasic square wave (10 positive pulses followed by 10 negative pulses). Device benefits include non-invasive cosmetic skin toning. Operated by the consumer at home.

Clinical Evidence

Bench testing only. Device demonstrated compliance with IEC 60601-1 (electrical safety) and IEC 60601-1-2 (EMC). Substantial equivalence is supported by identical technological characteristics to the predicate and usability studies.

Technological Characteristics

Injection-molded thermoplastic resin housing; chrome-plated spherical electrodes. Powered by rechargeable lithium-ion battery. Delivers constant biphasic square wave microcurrent (400 μA @ 500Ω; 28 VDC max). Frequency ~8.3 Hz; pulse width 60 msec. Microprocessor-controlled output intensity (1-5 levels). Type BF patient isolation. Complies with 21 CFR 898, IEC 60601-1, and IEC 60601-1-2.

Indications for Use

Indicated for over-the-counter cosmetic facial and neck skin stimulation.

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 Plus (K103472)

Submission Summary (Full Text)

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October 11, 2018

Carol Cole Company dba NuFACE Donald Ellis Head - Regulatory Affairs/ Quality Assurance 1325 Sycamore Ave. Suite A Vista. California 92081

Re: K181008

Trade/Device Name: NuFACE Trinity Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NFO Dated: August 14, 2018 Received: August 16, 2018

Dear Donald Ellis:

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. 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, 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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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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Vivek J. Pinto -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

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## Indications for Use

510(k) Number (if known) K181008

Device Name NuFACE Trinity

Indications for Use (Describe)

The NuFACE Trinity 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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#### NUFACE TRINITY DEVICE 510(K) SUMMARY

#### Date Prepared: August 14, 2018

#### 510(K) SUBMITTER/OWNER

Carol Cole Company dba NuFACE 1325 Sycamore Ave, Suite A Vista, CA 92081, USA

#### CONTACT INFORMATION:

Donald Ellis, Head - R&D Projects, Regulatory and Quality Phone: [phone] Facsimile: [phone] Email: [e-mail]

#### Device Names

Device Trade/ Proprietary Name: Device Common or Usual Name: Classification Name:

NuFACE Trinity Facial and Neck Skin Toning Device NuFACE Trinity Device Transcutaneous electrical nerve stimulator for pain relief 21 CFR 882.5890 NFO

Requlation Number: Product Code:

#### PREDICATE DEVICE

The legally marketed predicate device to which the Carol Cole Company is claiming equivalence for over-the-counter use:

510(k) Number: K103472 Manufacturer: Carol Cole Company dba NuFACE Trade Name: NuFACE Plus Product Code: NFO

#### Device Description

The NuFACE Trinity Device(proposed) is intended for facial and neck skin stimulation and is indicated for over-the-counter cosmetic use. It is identical to that of its NuFACE Plus (predicate) and its technological characteristics remain unchanged.

#### Intended Use

The NuFACE Trinity Device is intended for facial and neck stimulation and is indicated for overthe-counter cosmetic use.

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## Technological Characteristics

The NuFACE Trinity Device (proposed) is identical to that of its NuFACE Plus (predicate) and its technological characteristics remain unchanged. It produces microcurrent discharged through the two spherical probes.

## Non-Clinical Testing

The NuFACE Trinity device is identical to the predicate which was tested to the applicable standards for electrical safety, EMC, and biocompatibility. Literature provided and usability studies conducted demonstrate that the device is substantially equivalent to the predicate given the new indications.

## Performance Standards

The NuFACE Trinity Device (proposed) is identical to that of its NuFACE Plus (predicate) and both comply to FDA performance standards set forth in 21 CFR §898.

Product Safety and EMC performance testing was conducted for the following aspects:

- 1. Electrical and Constructional Safety in accordance with IEC 60601-1
- 2. Electromagnetic Compatibility (EMC) in accordance with IEC 60601-1-2

Thus, with respect to Safety and EMC, the NuFACE Trinity Device (proposed) is substantially equivalent to the NuFACE Plus (predicate).

| DEVICE DESCRIPTIONS | NuFACE TRINITY DEVICE<br>(PROPOSED) | NuFACE PLUS<br>(PREDICATE) | SAME OR<br>DIFFERENT | |
|-------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|---------|
| 1. 510(k) Number | K181008 | K103472 | | |
| 2. Regulation<br>Number | 21 C.F.R. § 882.5890 | 21 C.F.R. § 882.5890 | 21 C.F.R. §<br>882.5890 | |
| 3. Regulation<br>Name | Transcutaneous<br>electrical nerve<br>stimulator for pain relief | Transcutaneous<br>electrical nerve<br>stimulator for pain<br>relief | Same | |
| 4. Regulatory Class | Class II | Class II | Same | |
| 5. Device<br>Classification<br>Name | Stimulator,<br>Transcutaneous<br>Electrical, Aesthetic<br>Purposes | Stimulator,<br>Transcutaneous<br>Electrical, Aesthetic<br>Purposes | Same | |
| 6. Product Code | NFO | NFO | Same | |
| 7. Regulation<br>Medical<br>Specialty | Neurology | Neurology | Same | |
| 8. Intended Use | NuFACE Trinity Device is<br>intended for facial and<br>neck skin stimulation and<br>is indicated for over-the-<br>counter cosmetic use. | NuFACE Plus is<br>intended for facial<br>stimulation and is<br>indicated for over-<br>the-counter cosmetic<br>use. | Different | |
| 9. Indications for<br>Use | Over-the-Counter<br>Cosmetic Use | Over-the-Counter<br>Cosmetic Use | Same | |
| 10. Anatomic Sites | Face and Neck | Face | Different | |
| 11. Technological<br>Characteristics | The NuFACE Trinity<br>Device. Its outer case is<br>injection molded<br>thermoplastic resin. The<br>output contacts consist<br>of chrome-plated<br>spheres. The device is<br>powered by a<br>rechargeable lithium ion<br>battery and produces a<br>microcurrent that is<br>discharged through two<br>fixed, smooth electrode<br>spheres. To turn the<br>device on, the on/off<br>button is pressed.<br>Ascending tonal beeps<br>indicate the device is<br>on. One to five red LED<br>lights illuminate<br>indicating the output<br>intensity level and the<br>unit is ready for use.<br>Users then follow the<br>instructions for use. The<br>two spheres gently glide<br>over the skin to deliver<br>low-level electrical<br>impulses to targeted<br>locations. The NuFACE<br>Trinity spheres are<br>designed for optimal<br>contact with the skin.<br>The NuFACE Trinity<br>Device delivers<br>microcurrent as a<br>constant biphasic | The NuFACE Plus is a<br>facial toning device.<br>Its outer case is<br>injection molded<br>thermoplastic resin.<br>The output contacts<br>consist of chrome-<br>plated spheres. The<br>device is powered by<br>a rechargeable<br>lithium ion battery and<br>produces a<br>microcurrent that is<br>discharged through<br>two fixed, smooth<br>electrode spheres. To<br>turn the device on,<br>the on/off button is<br>pressed. Ascending<br>tonal beeps indicate<br>the device is on. One<br>to five red LED lights<br>illuminate indicating<br>the output intensity<br>level and the unit is<br>ready for use. Users<br>then follow the<br>instructions for use.<br>The two spheres<br>gently glide over the<br>skin to deliver low-<br>level electrical<br>impulses to targeted<br>locations. The<br>NuFACE Plus spheres<br>are designed for<br>optimal contact with | Same | |
| | | | | |
| BASIC UNIT<br>CHARACTERISTICS | square wave comprising<br>a (10) positive pulses<br>followed by (10)<br>negative pulses. The<br>microcurrent output<br>continuously alternates<br>between the positive<br>and negative electrode<br>spheres, and allows the<br>user to adjust the output<br>for a personalized<br>comfort level. The<br>NuFACE Trinity Device<br>requires the use of a<br>conductive gel. To<br>promote proper use and<br>provide feedback to the<br>user, the NuFACE Trinity<br>Device beeps to cue the<br>user to relocate the<br>device approximately<br>every 5 seconds. | the skin. The NuFACE<br>Plus device delivers<br>microcurrent as a<br>constant biphasic<br>square wave<br>comprising a (10)<br>positive pulses<br>followed by (10)<br>negative pulses. The<br>microcurrent output<br>continuously<br>alternates between<br>the positive and<br>negative electrode<br>spheres, and allows<br>the user to adjust the<br>output for a<br>personalized comfort<br>level. The NuFACE<br>Plus device requires<br>the use of a<br>conductive gel. To<br>promote proper use<br>and provide<br>feedback to the user,<br>the NuFACE Plus<br>beeps to cue the user<br>to relocate the<br>device approximately<br>every 5 seconds. | | |
| 1. 510(k) Number | K181008 | K103472 | Different | |
| 2. Device Name,<br>Model | NuFACE Trinity Device | NuFACE Plus | Same | |
| 3. Manufacturer | Carol Cole Company<br>(dba NuFACE) | Carol Cole Company<br>(dba NuFACE) | Same | |
| 4. Power Source(s) | Internal rechargeable<br>Lithium ion battery | Internal rechargeable<br>Lithium ion battery | Same | |
| a. Method of<br>Line Current<br>Isolation | Type BF | Type BF | Same | |
| b. Patient<br>Leakage<br>Current | | | | |
| 1). Normal<br>condition | N/A - Battery operated | N/A - Battery operated | Same | |
| 2). Single<br>fault condition | N/A - Battery operated | N/A - Battery operated | Same | |
| 5. External power<br>adapter | NuFACE 7-volt power<br>adapter | NuFACE 7-volt power<br>adapter | Same | |
| 6. Number of<br>Output<br>Channels | 1 | 1 | Same | |
| a. Synchronous<br>or Alternating | N/A - 1 Output channel | N/A - 1 Output channel | Same | |
| b. Method of<br>Channel<br>Isolation | N/A - 1 Output channel | N/A - 1 Output channel | Same | |
| 7. Regulated<br>Current or<br>Regulated<br>Voltage | Both | Both | Same | |
| 8. Software/Firmwa<br>re/Microproces<br>sor Control | Yes | Yes | Same | |
| 9. Automatic<br>Overload Trip | Not required due to<br>circuit design | Not required due to<br>circuit design | Same | |
| 10. Automatic No-<br>Load Trip | Yes | Yes | Same | |
| 11. Automatic Shut<br>Off | Yes | Yes | Same | |
| 12. Patient<br>Override<br>Control | Yes | Yes | Same | |
| 13. Indicator<br>Display | | | | |
| a. On/Off<br>Status | Yes | Yes | Same | |
| b. Low Battery | Yes | Yes | Same | |
| | c. Voltage/Curr<br>ent Level | Yes | Yes | Same |
| | 14. Automatic<br>Shut-Off<br>(minutes) | Yes (20 minutes) | Yes (20 minutes) | Same |
| | 15. Compliance<br>with Voluntary<br>Standards…