(121 days)
Not Found
No
The device description and performance studies focus on basic electrical stimulation parameters and control logic, with no mention of AI or ML technologies.
No
The device is described as being for "facial stimulation" and "over-the-counter cosmetic use," specifically to "increase facial contour and firm the skin and muscles," which are not considered therapeutic purposes.
No
The device is intended for facial stimulation for cosmetic use to increase facial contour and firm skin and muscles, not for diagnosing medical conditions.
No
The device description explicitly details physical hardware components including dual spheres, an outer case made of thermoplastic resin, internal batteries, and an external power supply. It also describes physical interactions like pressing a control button and relocating the device on the skin.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "facial stimulation" and "over-the-counter cosmetic use." This clearly indicates a purpose related to physical appearance and toning, not the diagnosis of diseases or conditions.
- Device Description: The description focuses on the physical characteristics, power supply, and how it delivers micro-current for facial toning. There is no mention of analyzing biological samples (like blood, urine, or tissue) or providing diagnostic information.
- Performance Studies: The performance studies described are focused on comparing the electrical output characteristics of the device to a predicate device, ensuring it functions as intended for facial stimulation. There are no studies related to diagnostic accuracy or the analysis of biological markers.
IVD devices are specifically designed to examine specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
The NuFACE® Mini Device is intended for facial stimulation and is indicated for overthe-counter cosmetic use. (21 CFR 801 Subpart C).
The NuFACE® Mini Facial Toning device is intended for facial stimulation and is indicated for over-the-counter cosmetic use (21 CFR 807 Subpart C).
Product codes (comma separated list FDA assigned to the subject device)
NFO
Device Description
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 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.
The NuFACE® Mini is a facial toning device. The chrome plated dual electrode 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. The NuFACE® Mini electrodes are designed for optimal contact with the face.
The NuFACE® Mini microcurrent continually alters between the positive and negative electrodes, and allows the user to adjust settings for a personalized comfort level. The outer case of the NuFACE® Mini is injection molded of thermoplastic resin. The device comes with an external Power Supply to charge the internal batteries of the device, when the device is 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, the control button is pressed. An ascending sequence of beeps and one to five 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 control button to shift between multiple microcurrent output levels. When the device is set to the maximum output and the control button is pressed, the device sequences to the minimum output. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
the face.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
at home, over-the-counter
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)
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:
- Waveform Type
- Waveform Shape
- Maximum Output Voltage
- Maximum Output Current
- Output Tolerance
- Pulse Width
- Output Frequency
- Maximum Phase Charge
- Maximum Current Density
- Maximum Power Density
- Burst Mode (i.e., pulse trains)
a. Pulses per burst
b. Pulses per second
C. Burst duration
d. Duty Cycle - ON Time
The results support a determination of substantial equivalence in that the NuFACE® Mini provides the same functionality and microcurrent output as the predicate.
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
510(k) Summary NuFACE® Mini Device
CONTACT INFORMATION
Rand Daoud. Compliance Specialist Carol Cole Company 1325 Sycamore Ave, Suite A Vista, California 92081
Phone: (760) 734-4545 x126 Facsimile: (760) 650-3667 Email: rdaoud@mynuface.com
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
1
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:
-
- Waveform Type
-
- Waveform Shape
-
- Maximum Output Voltage
-
- Maximum Output Current
-
- Output Tolerance
-
- Pulse Width
.
-
- Output Frequency
-
- Maximum Phase Charge
-
- Maximum Current Density
-
- Maximum Power Density
-
- Burst Mode (i.e., pulse trains)
- a. Pulses per burst
- b. Pulses per second
- Burst duration C.
- d. Duty Cycle
-
- ON Time
The results are provided in Section 3 (Output Specifications) below. As shown in the Substantial Equivalence Comparison Table:
-
- Waveform type is identical to the predicate
2
Waveform Shape is identical to the predicate 2.
-
Maximum Output Voltage is identical to the predicate
-
Maximum Output Current is identical to the predicate
-
- Output Tolerance is identical to the predicate
-
- Pulse Width is identical to the predicate
-
- Output Frequency is identical to the predicate
-
- Maximum Phase Charge is identical to the predicate
-
- Maximum Current Density is identical to the predicate
-
- Maximum Power Density is identical to the predicate
-
- 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
- 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.
3
Section 1: Device Descriptions
| Section 1: Device
Descriptions | NuFACE® Mini
New Device | NuFACE® Trinity
(Cleared as the NuFACE® Plus)
Predicate Device |
|---------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. 510(k) Number | K133823 | K103472 |
| 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® Mini is a facial toning device. The
chrome plated dual electrode 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. 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
for a personalized comfort level.
The outer case of the NuFACE® Mini is injection
molded of thermoplastic resin. The device comes
with an external Power Supply to charge the
internal batteries of the device, when the device is
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, the control button is
pressed. An ascending sequence of beeps and one
to five 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 control button to shift
between multiple microcurrent output levels.
When the device is set to the maximum output and
the control button is pressed, the device sequences
to the minimum output. 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® 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. |
| Section 2: Basic Unit
Characteristics | NuFACE® Mini Device
New Device | NuFACE® Trinity
(Cleared as the NuFACE® Plus)
- 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
Isolation | 2 rechargeable AA NiMH
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 |
| 7. Regulated Current or
Regulated Voltage? | Both | Both |
| 8. Software/Firmware/
Microprocessor Control? | Yes | Yes |
| 9. Automatic Overload Trip? | Not required due to circuit
design | Not required due to circuit design |
| 10. Automatic No-Load Trip? | Yes | Yes |
| 11. Automatic Shut Off? | Yes | Yes |
| 12. Patient Override Control? | Yes | Yes |
| 13. Indicator Display | | |
| a. On/Off Status? | Yes | Yes |
| b. Low Battery? | Yes | Yes |
| c. Voltage/Current Level? | Yes | Yes |
| 14. Timer Range (minutes) | Yes (21 minutes) | Yes (21 minutes) |
| 15. Compliance with Voluntary
Standards? | IEC 60601-1
IEC 60601-1-2 | IEC 60601-1
IEC 60601-1-2 |
| 16. Compliance with 21 CFR
898? | Yes | Yes |
| 17. Weight | 6 oz | 9 oz without charging base |
| 18. Dimensions of device(inch)
[W x L x D] | 2.5" W x 4.2" L x 1.2" D | 3" W x 5.2" L x 1.25" D |
| 19: Dimensions of charging Unit
(inch) [W x L x D] | None | 3.25" W x 4.0" L x 3.25" D |
| 20. Housing Materials and
Construction | Thermo Plastic | Thermo Plastic |
| Section 3: Output Specifications | NuFACE® Mini Device:
New Device. | NuFACE® Trinity
(Cleared as the NuFACE® Plus)
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) | 222 mV @ 500 Ω
781 mV @ 2 kΩ
3.90 V @ 10 kΩ | 137 mV @ 500 Ω
769 mV @ 2 kΩ
3.82 V @ 10 kΩ |
| Maximum Output Current (specify units) | 396 μA @ 500 Ω
395 μA @ 2 kΩ
391 μA @ 10 kΩ | 274 μA @ 500 Ω
387 μA @ 2 kΩ
383μA @ 10 kΩ |
| Output Current When On, But Not Stimulating
(Charging is the only case where this occurs) | 1.53 μA @ 10 kΩ | 27.8 μA @ 10 kΩ |
| Output Tolerance | +/- 2% | +/- 2% |
| Pulse Width (specify units) | ON phase: 60.4 ms
OFF phase: 60.4 ms
Total Pulse Width: 120.8 ms | 119 ms |
| Frequency (Hz) | 8.28 Hz | 8.40 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)
(state range, if applicable)
(both phases, if asymmetrical). | Not Multiphasic | Not Determined |
| Net Charge (µC per pulse) | 1.43 µC @ 500 Ω | 1.40 µC @ 500 Ω |
| Maximum Phase Charge (µC) | 23.7 µC @ 500 Ω | 23.6 µC @ 500 Ω |
| Maximum Current Density (mA/cm²) | 0.514 mA/cm² @ 500 Ω | 0.512 mA/cm² @ 500 Ω |
| Maximum Power Density (μW/cm²)
(using smallest electrode conductive surface area) | 1981 μW/cm² @ 10k Ω | 1991 μW/cm² @ 10k Ω |
| Patient Leakage Current During Charging With
Normal Mains Polarity | 0.5 μA RMS | 0.4 μA RMS |
| Patient Leakage Current During Charging With
Reversed Mains Polarity | 0.5 μA RMS | 0.6 μA RMS |
| Burst Mode (i.e., pulse trains) | | |
| a. Pulses per burst | 20 | 20 |
| b. Pulses per second | 8.28 | 8.40 |
| c. Burst duration (seconds) | 2.42 | 2.40 |
| d. Duty Cycle [Line (b) x Line (c)]
(on time per burst) | 20 | 20.2 |
| ON Time (seconds) | Constant | Constant |
| OFF Time (seconds) | None | None |
NuFACE® Mini and NuFACE® Trinity Device Comparison Table
4
Section 2: Basic Unit Characteristics
NuFACE® Mini and NuFACE® Trinity Device Substantial Equivalence Comparison Table
5
Section 3: Output Specifications NuFACE® Mini and NuFACE® Trinity Device Substantial Equivalence Comparison Table
6
Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract shapes that resemble bird wings or flowing lines, creating a sense of movement and representing the department's mission related to health and well-being.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002
April 17, 2014
Carol Cole Company Rand Daoud Compliance Specialist 1325 Sycamore Ave, Suite A Vista. California 92081
Rc: K133823
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: March 18, 2014 Received: March 19, 2014
Dear Ms. Daoud:
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 10 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 cither class II (Special Controls) or class III (PMA). it may be subject to additional controls. Existing major regulations affecting your device can be Tour 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 statutes and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21
7
Page 2 - Ms. Rand Daoud
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportaProblem/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 Industry and Consumer Education 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.
Sincerely yours,
Felipe Aguel -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
8
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K133823
Device Name
NuFACE® Mini Device
Indications for Use (Describe)
The NuFACE® Mini Facial Toning device is intended for facial stimulation and is indicated for over-the-counter cosmetic use (21 CFR 807 Subpart C).
Type of Use (Select one or both, as applicable)
[] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Date: 2014.04.17 Aqui 18:46:47 -04'00'
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
9
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