(348 days)
Not Found
No
The description focuses on microcurrent technology and basic electrical stimulation, with no mention of AI or ML algorithms for analysis, adaptation, or decision-making.
No
The device is described as an "Over-the-Counter Cosmetic Use" device for "facial stimulation" and "skin toning," which are cosmetic claims, not therapeutic ones.
No
The device description and intended use state that it is for facial stimulation and toning, delivering microcurrents for cosmetic use to contour and firm the skin and muscles. There is no mention of it diagnosing any medical condition or disease.
No
The device description clearly details physical hardware components including probes, an outer case, batteries, and a charging base, indicating it is a physical device, not software-only.
Based on the provided information, the NūFACE® Plus Facial Toning Device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is clearly stated as "facial stimulation" and "over-the-counter cosmetic use." This is a physical application to the body for cosmetic purposes, not for the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.
- Device Description: The device description details how it applies microcurrent to the face for toning and firming. This is a physical interaction with the body's tissues.
- Lack of Diagnostic Function: There is no mention of the device analyzing biological samples (like blood, urine, or tissue) or providing any diagnostic information about a person's health status.
- Anatomical Site: The anatomical site is the face, which is consistent with a cosmetic device.
- No Mention of IVD-related activities: The document does not mention any processes or functions related to in vitro diagnostics, such as sample collection, analysis of biological markers, or interpretation of diagnostic results.
In summary, the NūFACE® Plus is a cosmetic device that uses microcurrent for facial stimulation and toning. It does not perform any in vitro diagnostic functions.
N/A
Intended Use / Indications for Use
The NūFACE® Plus Facial Toning Device is intended for facial stimulation and is indicated for over-the-counter cosmetic use. (21 CFR 801 Subpart C).
Product codes
NFO
Device Description
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
The anatomical site for application of the NuFACE® Plus is the face.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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: (760) 734-4545 Facsimile: (760) 734-4565 Email: tvaldez@mvnuface.com 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.
1
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.
2
Section 1: Device Descriptions
| Section 1: Device Descriptions | NuFACE® Plus
New Device | NuFace® Original
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
outer case is injection molded thermoplastic resin.
The output contacts (probes) consist of chrome-plated
spheres. The device, powered by four rechargeable
AA nickel-metal hydride batteries, produces a micro-
current that is discharged through the two fixed,
smooth spherical probes. To turn the device on, the
on/off button is pressed. An ascending tone sounds,
indicating the device on. One to five red LED lights
illuminate indicating the unit is ready for use. 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.
The NuFACE® Plus probes are designed for optimal
contact with the face. The NuFACE® Plus micro-
current continually alternates between the positive
and negative probes, and allows the user to adjust
settings for a personalized comfort level. The
NuFACE® Plus device requires the use of a
conductive solution or gel. To promote proper use
and feedback to the user, the NuFACE® Plus beeps
to cue the user to relocate the device approximately
every 5 seconds. The beep also informs the user that
the two spheres are making contact with the skin
surface. An alert tone sounds to indicate that both
probes are not touching the skin during treatment. | NuFace® is a facial toning device. Its outer case is
injection molded thermoplastic resin, and the output
contacts (probes) consist of chrome-plated spheres.
The device, powered by a 9-volt battery, produces a
micro-current that is discharged through the two fixed,
smooth spherical probes. To turn the device on, the
thumbwheel is pushed upwards. A Green LED light
will then illuminate, indicating the unit is ready for use.
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.
The NuFace® probes are designed for optimal contact
with the face. The NuFace® device micro-current
continually alternates between the positive and
negative probes, and allows the user to adjust settings
for a personalized comfort level. The NuFace® device
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
·
・
ﮐﯽ
·
3
Section 2: Basic Unit Characteristics
NuFACE® Plus and Original NuFace® Device Substantial Equivalence Comparison Table
.
| Section 2: Basic Unit Characteristics | NuFACE® Plus
New Device | NuFace® Original
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 |
. .
4
Section 3: Output Specifications
| Output Specifications | |
|---|---|
| NuFACE® Plus and Original NuFace® Device Substantial Equivalence Comparison Table |
| Section 3: Output Specifications | NuFACE® Plus
New Device | NuFace® Original
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 |
5
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.
6
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 (800) 638-2041 or (301) 796-7100 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
7
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