(587 days)
Not Found
No
The summary describes a simple electrical stimulation device with no mention of AI/ML terms, image processing, or data sets for training/testing.
No
The device is indicated for cosmetic use to stimulate the face, not for treating or preventing a disease or condition.
No
The device is described as "intended to stimulate the face" and "indicated for cosmetic use," which points to a therapeutic or cosmetic purpose rather than diagnostic. There is no mention of identifying, detecting, or measuring a disease, condition, or physiological state.
No
The device description explicitly states it is a "battery-powered hand-held non-prescription device" with "electrodes that are built into the body of the device," indicating it is a hardware device with electrical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "stimulate the face" for "cosmetic use." This is a physical or aesthetic purpose, not for diagnosing, monitoring, or treating a disease or condition based on in vitro examination of specimens derived from the human body.
- Device Description: The device delivers electrical pulses to the face via electrodes. This is a direct interaction with the body's surface, not an analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. There is no indication of a diagnostic purpose.
IVD devices are specifically designed to perform tests on samples taken from the body to provide information about a person's health. This device does not fit that description.
N/A
Intended Use / Indications for Use
The NutritoneTM Facial Beauty System is intended to stimulate the face. The device is indicated for cosmetic use.
Product codes
NFO
Device Description
The NutritoneTM Facial Beauty System is a battery-powered hand-held non-prescription device. Its output is a series of electrical pulses that are delivered to the user's face via electrodes that are built into the body of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
K070250
SEP - 4 2008
510(k) Summary
26
NutritoneTM Facial Beauty System
Common/Classification Name:
Stimulator, Transcutaneous Electrical, for Cosmetic Use
21 CFR 882.5890
Sponsor:
Isomers Laboratories, Inc. Attn: Dariush Majlessi, President 105 Tycos Drive, Toronto, ON, M6B 1W3 Canada
Contact:
RegTech Solutions, LLC Attn: Robert Mazzaferro, Manager 11 Dellcastle Court Montgomery Village, MD 20886
Prepared: September 9, 2007
LEGALLY MARKETED PREDICATE DEVICE
For its indication for use, the Nutritone™ Facial Beauty System is substantially equivalent to the Face Master Facial Toning System cleared by FDA under K040871.
DEVICE DESCRIPTION
The Nutritone™ Facial Beauty System is a battery-powered hand-held non-prescription device. Its output is a series of electrical pulses that are delivered to the user's face via electrodes that are built into the body of the device. A table comparing the intended was and mechanical and electrical properties of this device is presented below.
SUBSTANTIAL EQUIVALENCE SUMMARY
A comparison of the Nutritone™ Facial Beauty System and the Face Master Facial Toning System is presented in the table below.
1
| Specification | New Device - Isomers
Nutritone™ Facial Beauty
System | Predicate - Face Master
K040871 |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Intended Use | The device is intended to
stimulate the face and it is
indicated for cosmetic use. | The device is intended to
stimulate the face and it is
indicated for cosmetic use. |
| Size: Body | 45mm wide x 30mm thick x
131.5mm long | Not known |
| Weight | Mass is about 95 grams | Not known |
| User interface | Treatment area slide switch
thumbwheel output control and a
lighted "on" indicator. | LCD display, on-off switch, and
program & intensity selectors |
| Housing
materials and
construction | Housing made from ABS plastic
& output contacts made from
brass with a conductive silver
coating. | Housing material not known.
Device has external probes that
plug into it. |
| Output
Channel | Single | Single |
| Energy source | One 9V alkaline battery | One 9V battery |
| Timer range | Stimulation time controlled
manually. Maximum fixed "on"
time is 3- or 12-minutes
depending on the selected
treatment area | Stimulation time controlled
manually. No apparent maximum
fixed "on" time |
| Max Vo-pk into
10kΩ | 7.5 | 7.0 |
| Waveform | Rectangular bipolar pulses | Rectangular bipolar pulses |
| Frequency &
Pulse Width | Either 0.6Hz & 400ms or 5.3Hz &
50ms depending on treatment
area | Either 0.6Hz & 400ms or 5.3Hz
& 50ms depending on treatment
area |
| Duty cycle | 50% | 50% |
| User controls | Uncalibrated thumbwheel on-
off/amplitude & mode (treatment
area) slide switch | On-off switch and program &
amplitude selectors |
| Software or
microprocessor | None is used | Not known |
| Compliance
with 21 CFR
898 | Not applicable. Device does not
have external leads. | Complies with this standard. |
Table 1 Comparison of New Device & Predicate Device
Comparison of the toning gels and solutions used by the Nutritone™ & FaceMaster devices plus one other similar cleared device revealed the composition of each product is very similar.
CONCLUSION: Since the intended use is the same and the technological characteristics are so similar we believe that this pre-market submission demonstrates substantial equivalence (SE) to a legally marketed predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 4 2008
Isomer Laboratories, Inc. % Regtech Solutions, LLC Mr. Robert Mazzaferro 11 Dellcastle Court Montgomery Village, Maryland 20886
Re: K 070250
Trade/Device Name: Nutritone™ Beauty System Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NFO Dated: June 5, 2008 Received: June 6, 2008
Dear Mr. Mazzaferro:
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 indictions for use stated in the enclosure) to legally marketed predicate devices marketed in introlled 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, I inte not devices, good manufacturing practice, labeling, and prohibitions against misbrandijng 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. Robert Mazzaferro
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 marketed predicate 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 Comrinions 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 Systeros 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 Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Millman
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name: Nutritone™ Facial Beauty System
Indications for Use: The Nutritone™ Facial Beauty System is intended to stimulate the face. The device is indicated for cosmetic use.
Prescription Use (Per 21 CFR 801 Subpart D) Over-The-Counter Use × (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1.
Mark M. Milkenon
(Division Sign-Off) Division of General, Restorative, and Neurological Devices 070250 510(k) Number