NUTRITONE FACIAL BEAUTY SYSTEM

K070250 · Isomers Laboratories, Inc. · NFO · Sep 4, 2008 · Neurology

Device Facts

• Record ID: K070250
• Device Name: NUTRITONE FACIAL BEAUTY SYSTEM
• Applicant: Isomers Laboratories, Inc.
• Product Code: NFO · Neurology
• Decision Date: Sep 4, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Nutritone™ Facial Beauty System is intended to stimulate the face. The device is indicated for cosmetic use.

Device Story

Nutritone™ Facial Beauty System is a battery-powered, hand-held, over-the-counter device for cosmetic facial stimulation. Device delivers electrical pulses to the face via integrated electrodes. User interface includes a treatment area slide switch, thumbwheel output control, and lighted 'on' indicator. Device operates on a 9V alkaline battery. Output consists of rectangular bipolar pulses with selectable frequencies (0.6Hz or 5.3Hz) and pulse widths (400ms or 50ms) based on treatment area. Stimulation time is manually controlled with fixed maximum 'on' times of 3 or 12 minutes. Device is intended for home use by the consumer to provide cosmetic facial stimulation.

Clinical Evidence

No clinical data. Substantial equivalence is based on technological characteristics and comparison of electrical/mechanical specifications to the predicate device.

Technological Characteristics

Hand-held, battery-powered (9V alkaline) stimulator. Housing: ABS plastic. Electrodes: brass with conductive silver coating. Output: single channel, rectangular bipolar pulses. Frequency/Pulse Width: 0.6Hz/400ms or 5.3Hz/50ms. Duty cycle: 50%. User controls: manual thumbwheel and slide switch. No software or microprocessor used. No external leads.

Indications for Use

Indicated for cosmetic facial stimulation in general population users.

Regulatory Classification

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.

Predicate Devices

• Face Master Facial Toning System (K040871)

Submission Summary (Full Text)

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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.

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| Specification | New Device - Isomers<br>Nutritone™ Facial Beauty<br>System | Predicate - Face Master<br>K040871 |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Intended Use | The device is intended to<br>stimulate the face and it is<br>indicated for cosmetic use. | The device is intended to<br>stimulate the face and it is<br>indicated for cosmetic use. |
| Size: Body | 45mm wide x 30mm thick x<br>131.5mm long | Not known |
| Weight | Mass is about 95 grams | Not known |
| User interface | Treatment area slide switch<br>thumbwheel output control and a<br>lighted "on" indicator. | LCD display, on-off switch, and<br>program & intensity selectors |
| Housing<br>materials and<br>construction | Housing made from ABS plastic<br>& output contacts made from<br>brass with a conductive silver<br>coating. | Housing material not known.<br>Device has external probes that<br>plug into it. |
| Output<br>Channel | Single | Single |
| Energy source | One 9V alkaline battery | One 9V battery |
| Timer range | Stimulation time controlled<br>manually. Maximum fixed "on"<br>time is 3- or 12-minutes<br>depending on the selected<br>treatment area | Stimulation time controlled<br>manually. No apparent maximum<br>fixed "on" time |
| Max Vo-pk into<br>10kΩ | 7.5 | 7.0 |
| Waveform | Rectangular bipolar pulses | Rectangular bipolar pulses |
| Frequency &<br>Pulse Width | Either 0.6Hz & 400ms or 5.3Hz &<br>50ms depending on treatment<br>area | Either 0.6Hz & 400ms or 5.3Hz<br>& 50ms depending on treatment<br>area |
| Duty cycle | 50% | 50% |
| User controls | Uncalibrated thumbwheel on-<br>off/amplitude & mode (treatment<br>area) slide switch | On-off switch and program &<br>amplitude selectors |
| Software or<br>microprocessor | None is used | Not known |
| Compliance<br>with 21 CFR<br>898 | Not applicable. Device does not<br>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.

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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.

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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 [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systeros at [phone]. 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 [phone] or [phone] 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

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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