(113 days)
Not Found
No
The description focuses on electrical impulses and user-adjustable settings, with no mention of AI/ML terms or functionalities.
No.
The device is intended for facial and neck stimulation and toning, which are cosmetic purposes, not for treating a disease or condition.
No
The device is described as "intended for facial and neck stimulation" and a "facial and neck toning device," with no mention of diagnosing conditions.
No
The device description clearly outlines physical hardware components including chrome plated dual spheres, an outer case of injection mold thermoplastic resin, and an external power supply. The performance studies also focus on electrical and constructional safety and electromagnetic compatibility, which are related to hardware performance.
Based on the provided information, the NuFACE Mini Device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "facial and neck stimulation" for "toning." This is a physical effect on the body, not a diagnostic test performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: The device delivers "low-level electrical impulses" to the skin. This is a form of physical therapy or cosmetic treatment, not a method for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The NuFACE Mini Device is clearly described as a device for physical stimulation of the face and neck for cosmetic purposes.
N/A
Intended Use / Indications for Use
The NuFACE Mini Device is intended for facial and neck stimulation and is indicated for over-the-counter use.
Product codes (comma separated list FDA assigned to the subject device)
NFO
Device Description
The NuFACE® Mini Device is an over-the- counter facial and neck toning device. The chrome plated dual spheres of the NuFACE® Mini are designed to gently glide over the skin to deliver low-level electrical impulses to strategic locations on the face and neck. The NuFACE® Mini electrodes are designed for optimal contact with the face.
The NuFACE® Mini microcurrent continually alternates between the positive electrodes and allows the user to adjust settings.
The NuFACE® Mini Device measures approximately 2.5" W x 4.2" D. Its outer case is injection mold thermoplastic resin. The device comes with an external Power Supply to recharge the lithium ion battery of the device when not in use. The external Power Supply is a pre- approved wall adapter. All charging circuitry is contained within the device itself.
To turn the device on/off, the power/control button is pressed. An ascending sequence of beeps and one to five blue LED lights illuminate indicating the unit is ready for use.
Users then follow the instructions for use. The NuFACE® Mini Device requires the use of a conductive gel or medium during treatment. The user can also adjust the output level by briefly pressing the power/control button to rotate between three microcurrent output levels. A long press of this button toggles the device on and off.
To promote proper use and feedback to the NuFACE® Mini beeps to cue the user to relocate the device after approximately 5 seconds of treatment. When the user turns off the device, a descending tone is emitted.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Face 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)
Product Safety and EMC performance testing was conducted for the following aspects:
-
- Electrical and Constructional Safety in accordance with IEC 60601-1
- Electromagnetic Compatibility (EMC) in accordance with IEC 60601-1-2 2.
-
- IEC 60601-2-10
-
- IEC 60601-1-11
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. To the right, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" below. The logo is simple and professional, reflecting the organization's role in regulating food and drugs.
October 15, 2019
Carol Cole Company dba NuFACE Nadia Miller Regulatory Affairs Specialist 1325 Sycamore Avenue, Suite A Vista, California 92081
Re: K191672
Trade/Device Name: NuFACE Mini Device Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NFO Dated: August 16, 2019 Received: August 16, 2019
Dear Nadia Miller:
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 avare 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.
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 Advice (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,
For Vivek Pinto Division Director (Acting) 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) K191672
Device Name
NuFACE Mini Device
Indications for Use (Describe)
The NuFACE Mini Device is intended for facial and neck stimulation and is indicated for over-the-counter 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
NUFACE
NuFACE Mini Device 510(K) Summary
Date Prepared: June 20, 2019
510(к) Submitter/ Owner
Carol Cole Company dba NuFACE 1325 Sycamore Ave, Suite A Vista, CA 92081, USA
Contact Information
Nadia Vazirzadeh Miller- Regulatory Affairs Specialist Phone: (760) 509-1259 Facsimile: (760) 650-3124 Email: nvazirzadeh@mynuface.com
Device Names
Device Trade/ Proprietary Name: Device Common or Usual Name: Classification Name: Regulation Number: Product Code:
NuFACE Mini Facial and Neck Skin Toning Device NuFACEMini Device Transcutaneous electrical nerve stimulator for pain relief 21 CFR 882.5890 NFO
Predicate Device
The legally marketed predicate device to which the Carol Cole Company is claiming equivalence for over-thecounter use:
| 510(k) Number: | K181008 |
|---|---|
| Manufacturer: | Carol Cole Company dba NuFACE |
| Trade Name: | NuFACE Trinity Device |
| Product Code: | NFO |
Device Description
The NuFACE® Mini Device is an over-the- counter facial and neck toning device. The chrome plated dual spheres of the NuFACE® Mini are designed to gently glide over the skin to deliver low-level electrical impulses to strategic locations on the face and neck. The NuFACE® Mini electrodes are designed for optimal contact with the face.
The NuFACE® Mini microcurrent continually alternates between the positive electrodes and allows the user to adjust settings.
The NuFACE® Mini Device measures approximately 2.5" W x 4.2" D. Its outer case is injection mold thermoplastic resin. The device comes with an external Power Supply to recharge the lithium ion battery of the device when not in use. The external Power Supply is a pre- approved wall adapter. All charging circuitry is contained within the device itself.
4
NUFA
To turn the device on/off, the power/control button is pressed. An ascending sequence of beeps and one to five blue LED lights illuminate indicating the unit is ready for use.
Users then follow the instructions for use. The NuFACE® Mini Device requires the use of a conductive gel or medium during treatment. The user can also adjust the output level by briefly pressing the power/control button to rotate between three microcurrent output levels. A long press of this button toggles the device on and off.
To promote proper use and feedback to the NuFACE® Mini beeps to cue the user to relocate the device after approximately 5 seconds of treatment. When the user turns off the device, a descending tone is emitted.
Intended Use
The NuFACE Mini Device is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use.
Technological Characteristics
The NuFACE Mini Device (proposed) is substantially equivalent to that of its NuFACE Trinity (predicate) and its technological characteristics are virtually identical/ equivalent. It produces microcurrent discharged through the two spherical electrodes.
Biocompatability
User contacting materials for NuFACE Mini are identical and manufactured identically to those of the predicate device. All materials were previously tested and shown to be biocompatible.
Performance Standards
The NuFACE Mini Device (proposed) is substantially equivalent to that of its NuFACE Trinity (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:
-
- Electrical and Constructional Safety in accordance with IEC 60601-1
- Electromagnetic Compatibility (EMC) in accordance with IEC 60601-1-2 2.
-
- IEC 60601-2-10
-
- IEC 60601-1-11
5
N U F A C E*
Table 1. Device Description Comparison
| Device Description | NUFACE Mini
(Proposed) | NUFACE Trinity
(Predicate) | Same or
Different
Technological
Characteristics |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| 1. 510(k) Number | TBD | K181008 | - |
| 2. Regulation Number | 21 C.F.R. § 882.5890 | 21 C.F.R. § 882.5890 | Same |
| 3. Regulation Name | Transcutaneous electrical nerve
stimulator for pain relief | Transcutaneous electrical nerve
stimulator for pain relief | Same |
| 4. Regulatory Class | Class II | Class II | Same |
| 5. Device Classification
Name | Stimulator, Transcutaneous Electrical,
Aesthetic Purposes | Stimulator, Transcutaneous Electrical,
Aesthetic Purposes | Same |
| 6. Product Code | NFO | NFO | Same |
| 7. Regulation Medical
Specialty | Neurology | Neurology | Same |
| 8. Intended Use | NuFACE Mini Device is intended for facial
and neck stimulation and is indicated for
over-the- counter cosmetic use. | NuFACE Trinity Device is intended for
facial and neck stimulation and is
indicated for over-the-counter
cosmetic use. | Same |
| 9. Indications for Use | Over-the-Counter Cosmetic Use | Over-the-Counter Cosmetic Use | Same |
| 10. Anatomic Sites | Face and Neck | Face and Neck | Same |
6
NUFACE®
- Technological Characteristics
The NuFACE® Mini Device is an over-thecounter facial and neck toning device. The chrome plated dual spheres of the NuFACE® Mini are designed to gently glide over the skin to deliver low-level electrical impulses to strategic locations on the face and neck. The NuFACE® Mini electrodes are designed for optimal contact with the face.
The NuFACE® Mini microcurrent continually alternates between the positive and negative electrodes and allows the user to adjust settings.
The NuFACE® Mini device measures approximately 2.5" W x 4.2" L x 1.2" D. Its outer case is injection mold thermoplastic resin. The device comes with an external Power Supply to recharge the lithium ion battery of the device when not in use. The external Power Supply is a pre- approved wall adapter. All charging circuitry is contained within the device itself.
To turn the device on/off, the power/control button is pressed. An ascending sequence of beeps and one to five blue LED lights illuminate indicating the unit is ready for use. Users then follow the instructions for use. The NuFACE® Mini Device requires the use of a conductive gel or medium during treatment. The user can also adjust the output level by briefly pressing the power/control button to rotate between three microcurrent output levels. A long press of this button toggles the device on and off. To promote proper use and feedback to the user, the NuFACE® Mini beeps to cue the user to relocate the device after approximately 5 seconds of treatment. When the user turns off the device, a descending tone is emitted.
The NuFACE® Trinity Device is an overthe-counter facial and neck toning device. Its outer case is injection molded thermoplastic resin. The output contacts consist of chromeplated spheres. The device is powered by a rechargeable lithium ion battery and produces a microcurrent that is discharged through two fixed, smooth electrode spheres. To turn the device on, the on/off button is pressed. Ascending tonal beeps indicate the device is on. One to five red LED lights illuminate indicating the output intensity level and the unit is ready for use. Users then follow the instructions for use. The two spheres gently glide over the skin to deliver low-level electrical impulses to targeted locations. The NuFACE Trinity spheres are designed for optimal contact with the skin. The NuFACE Trinity device delivers microcurrent as a constant biphasic square wave comprising a (10) positive pulses followed by (10) negative pulses. The microcurrent output continuously alternates between the positive and negative electrode spheres and allows the user to adjust the output for a personalized comfort level. The NuFACE Trinity requires the use of a conductive gel. To promote proper use and provide feedback to the user, the NuFACE Trinity beeps to cue the user to relocate the device approximately every 5 seconds.
Same
7
NUFACE®
Table 2. Basic Unit Characteristics Comparison
| Basic Unit Characteristics | NUFACE Mini
(Proposed) | NUFACE Trinity
(Predicate) | Same or Different
Technological
Characteristics |
|--------------------------------------------------------------|----------------------------------------------|----------------------------------------------|-------------------------------------------------------|
| 1. 510(k) Number | TBD | K181008 | |
| 2. Device Name, Model | NuFACE Mini | NuFACE Trinity | |
| 3. Manufacturer | Carol Cole Company dba
NuFACE | Carol Cole Company dba
NuFACE | Same |
| 4. Power Source(s) | Internal rechargeable Lithium
ion battery | Internal rechargeable
Lithium ion battery | Same |
| a. Method of Line Current
Isolation | Type BF | Type BF | Same |
| b. Patient Leakage Current | | | |
| 1). Normal condition | N/A - Battery operated | N/A - Battery operated | Same |
| 2). Single fault condition | N/A - Battery operated | N/A - Battery operated | Same |
| 5. External power adapter | NuFACE 5-volt
power adapter | NuFACE 7-volt
power adapter | Same |
| 6. Number of Output Channels | । | । | Same |
| a. Synchronous or Alternating | N/A - 1 Output channel | N/A - 1 Output channel | Same |
| b. Method of Channel Isolation | N/A - 1 Output channel | N/A - 1 Output channel | Same |
| 7. Regulated Current or Regulated Voltage | Both | Both | Same |
| 8. Software/Firmware/Microprocess
or Control | Yes | Yes | Same |
| 9. Automatic Overload Trip | Not required due to circuit
design | Not required due to
circuit design | Same |
| 10. Automatic No- Load Trip | Yes | Yes | Same |
| 11. Automatic Shut Off | Yes | Yes | Same |
| 12. Patient Override Control | Yes | Yes | Same |
| 13. Indicator Display | | | |
| a. On/Off Status | Yes | Yes | Same |
| b. Low Battery | Yes | Yes | Same |
| c. Voltage/Current Level | Yes | Yes | Same |
| 14. Automatic Shut- Off (minutes) | Yes (5 minutes) | Yes (20 minutes) | Same |
| 15. Compliance with Voluntary
Standards | IEC 60601-1
IEC 60601-1-2 | IEC 60601-1
IEC 60601-1-2 | Same |
| 16. Compliance with 21 CFR 898 | Yes | Yes | Same |
| 17. Weight | 6 oz. | 9 oz. without charging base | Same |
| 18. Dimensions of device(inch) [W x L x D] | 2.5" x 4.2" x 1.2" | 2.8" x 5.1" x 1.3" | Same |
| 19. Housing Materials and Construction | Thermoplastic | Thermoplastic | Same |
| Output Specifications | NUFACE Mini
(Proposed) | NUFACE Trinity
(Predicate) | Same or Different
Technological
Characteristics |
| 1. 510(k) Number | TBD | K181008 | - |
| 2. Waveform (e.g., pulsed monophasic,
biphasic) | Pulsed Biphasic | Pulsed Biphasic | Same |
| 3. Shape (e.g., rectangular, spike,
rectified sinusoidal) | Modulated Square | Modulated Square | Same |
| 4. Maximum Output Voltage | 28VDC | 28 VDC | Same |
| 5. Maximum Output Current | $348 \mu A$ at 500 Ω | $400 \mu A$ at 500 Ω | Same |
| 6. Maximum Output Current
Density | 0.452 mA/cm² | 0.419 mA/cm² | Same |
| 7. Output Current when not stimulating |