(105 days)
Not Found
No
The device description focuses on electrical stimulation and adjustable settings, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
The "Intended Use / Indications for Use" states it is "intended for facial stimulation and is indicated for over-the-counter cosmetic use," not for therapeutic purposes. While it mentions compliance with medical device standards and comparability to TENS devices (which can be therapeutic), its explicitly stated indication is cosmetic.
No
The device is described as a "Facial Toning Device" for "facial stimulation" and "over-the-counter cosmetic use," with no mention of diagnosing any medical condition.
No
The device description explicitly details physical hardware components including an injection molded case, chrome-plated probes, a 9-volt battery, and an LED light. It also describes the physical mechanism of action (delivering electrical impulses through probes).
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "facial stimulation" for "over-the-counter cosmetic use." IVDs are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for diagnosis, monitoring, or screening. This device is applied externally to the face for cosmetic purposes.
- Device Description: The description details a device that delivers electrical impulses to the skin. This is a physical interaction with the body, not an analysis of a biological sample.
- Anatomical Site: The anatomical site is the face, which is where the device is applied externally. IVDs work with internal biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens.
- Providing diagnostic information.
- Using reagents or assays.
- Measuring biomarkers or other biological indicators.
The device is clearly described as a facial toning device for cosmetic use, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The NuFace® 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
NuFace® is a Facial Toning Device intended for facial stimulation. The device measures 7" L x 2.5" W x 1" D. Its outer case is injection molded of thermoplastic resin, ABS UL 94 HB, and the output contacts (probes) consist of chrome-plated spheres. The device, powered by a 9-volt battery, produces microcurrent 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 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 NuFace® device requires the use of a conductive derma gel.
The NuFace® device is quite different from both Electrical Nerve Stimulation Devices and Electro-Muscle Stimulation Devices, which use a much stronger current to cause muscular contraction or nerve stimulation.
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 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The NuFace® Facial Toning Device was tested and found to be in compliance with FDA's performance standards set forth in 21 C.F.R. §898.
The NuFace device was also tested and found to be in compliance with the EU Declaration of Conformity under the EMC and Safety Standards IEC 60601-1 and IEC 60601-1-2. Accordingly, NuFace® has received a CE Mark under the Medical Device Directive 93/42/EEC.
The non-clinical performance data from the comparative analyses of the NuFace device and the two 510(k) approved predicate devices demonstrated the NuFace® device is as safe and effective as, and performs similarly to, the predicate 510(k) approved transcutaneous electrical nerve stimulator devices for OTC cosmetic use. Several other devices on the U.S. market that are not 510(k) approved yet have their device listed on the FDA website were not included in the comparative analysis (e.g., Arasys and Bio-Dermology).
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/1 description: The image is a black square with a white border. Inside the square is a white design that looks like two letter 'T's stacked on top of each other. The design is symmetrical and the two 'T's are facing each other. The background is black, which makes the white design stand out.
CAROLCOLE
510(k) Summary NuFace® Device
Date Prepared: August 10, 2007
CONTACT INFORMATION
Carol Cole Company 147 Basil Street Encinitas, California 92024
NOV 2 7 2007
Phone: (888) 360-9171 Facsimile: (760) 942-1292 Email: cc@carolcolecompany.com Contact Person: Carol Cole, President & CEO
DEVICE NAMES
Trade Name: NuFace® Common Name: Facial Toning Device Classification Name: Transcutaneous Electrical Nerve Stimulator (21 CFR 882.5890, Product Code: NFO)
PREDICATE DEVICES
The legally marketed predicate devices to which the Carol Cole Company is claiming equivalence include the following transcutaneous electrical nerve stimulator devices for cosmetic use:
510(k) Number: K040871 Manufacturer: FaceMaster of Beverly Hills, Inc. Trade Name: FaceMaster Facial Toning System Product Code: NFO
510(k) Number: K011935 Manufacturer: Salton, Inc. Trade Name: Rejuvenique Product Codes: NFO and GYB
INDICATIONS FOR USE/INTENDED USE
The NuFace® Facial Toning Device is intended for facial stimulation and is indicated for over-the-counter cosmetic use. (21 CFR 807 Subpart C).
The anatomical site for application of the NuFace is the face.
Carol Cole Company NuFace® Device 510(k) Summary 5-1
1
TECHNOLOGICAL CHARACTERISTICS
NuFace® is a Facial Toning Device intended for facial stimulation. The device measures 7" L x 2.5" W x 1" D. Its outer case is injection molded of thermoplastic resin, ABS UL 94 HB, and the output contacts (probes) consist of chrome-plated spheres. The device, powered by a 9-volt battery, produces microcurrent 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 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 NuFace® device requires the use of a conductive derma gel.
The NuFace® device is quite different from both Electrical Nerve Stimulation Devices and Electro-Muscle Stimulation Devices, which use a much stronger current to cause muscular contraction or nerve stimulation.
PERFORMANCE DATA
The NuFace® Facial Toning Device was tested and found to be in compliance with FDA's performance standards set forth in 21 C.F.R. §898.
The NuFace device was also tested and found to be in compliance with the EU Declaration of Conformity under the EMC and Safety Standards IEC 60601-1 and IEC 60601-1-2. Accordingly, NuFace® has received a CE Mark under the Medical Device Directive 93/42/EEC.
The non-clinical performance data from the comparative analyses of the NuFace device and the two 510(k) approved predicate devices demonstrated the NuFace® device is as safe and effective as, and performs similarly to, the predicate 510(k) approved transcutaneous electrical nerve stimulator devices for OTC cosmetic use. Several other devices on the U.S. market that are not 510(k) approved yet have their device listed on the FDA website were not included in the comparative analysis (e.g., Arasys and Bio-Dermology).
SUBSTANTIAL EQUIVALENCE
Based on the foregoing, the NuFace® device was found to have the same intended use and indication for use as the predicate devices. The device also has similar technological characteristics to its predicate devices. Minor differences in the technological characteristics of the NuFace® device and the predicate devices do not raise any issues of safety or effectiveness. Thus, the Carol Cole Company found the NuFace® device to be substantially equivalent to the legally marketed predicate devices labeled for over-the-counter cosmetic facial toning.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services, USA. 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 emblem resembling an eagle or bird-like figure with three curved lines representing wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Carole Cole Company % Global Life Sciences, Inc. Mr. Howard Asher President and CEO 3366 N. Torrey Pines Ct Suite 130 La Jolla, CA 92037
NOV 2 7 2007
K072260 Re: Trade/Device Name: NuFace® Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: NFO Dated: October 30, 2007 Received: October 31, 2007
Dear Mr. Asher:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 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); 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.
3
Page 2 - Mr. Howard Asher
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally premained notificate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely v
for Ato
Mark N. Melkerson
Dr
1/26/02
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows a logo with the text "CAROLCOLE" written in a serif font. Above the text is a square containing a stylized, intertwined "C" design. The square has a black background with a white border, making the white "C" design stand out. The logo appears to be for a brand or company named Carol Cole.
Indications for Use NuFace® Device
510(k) Number: K072260
Indications For Use:
The NuFace® Facial Toning Device is intended for facial stimulation and indicated for over-the-counter cosmetic use.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
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)
Sign-Division (Division Sign-ral, Restorative, Division of Occal Devices
510(k) Numbe
Carol Cole Company NuFace® Device Indications for Use