FACEMASTER FACIAL TONING SYSTEM

K040871 · Facemaster of Beverly Hills, Inc. · NFO · Jun 1, 2005 · Neurology

Device Facts

• Record ID: K040871
• Device Name: FACEMASTER FACIAL TONING SYSTEM
• Applicant: Facemaster of Beverly Hills, Inc.
• Product Code: NFO · Neurology
• Decision Date: Jun 1, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The FaceMaster Facial Toning System ("FaceMaster System") is intended to stimulate the face. The device is indicated for cosmetic use.

Device Story

FaceMaster Facial Toning System is a transcutaneous electrical nerve stimulator (TENS) for cosmetic facial muscle stimulation. Device consists of a control module and two handheld probes. User prepares device by dispensing conductive solution into a basin, soaking foam pads attached to probe tips. User operates device via control module buttons, following LCD and audible prompts to execute three stimulation cycles: eye, facial, and feathering. Device is intended for home use by the consumer. Electrical stimulation is delivered to facial muscles to achieve cosmetic toning effects.

Clinical Evidence

Clinical study conducted including trained observers and self-assessments to demonstrate substantial equivalence to other TENS devices for OTC cosmetic use.

Technological Characteristics

Transcutaneous electrical nerve stimulator; handheld probes with foam pads; conductive solution interface; LCD and audible user interface; complies with 21 C.F.R. § 898.12 for electrode lead wires and patient cables.

Indications for Use

Indicated for cosmetic facial stimulation. Intended for over-the-counter use.

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

• Rejuvenique® Facial Toning System, Model RJV-10 (Salton, Inc.)

Submission Summary (Full Text)

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# K040871

### JUN 1 - 2005

### 510(k) SUMMARY

### FaceMaster of Beverly Hills, Inc. FaceMaster® Facial Toning System

### Submitter's Name, Address, Telephone Number, Contact Person, and Date Prepared

FaceMaster of Beverly Hills, Inc. 23679 Calabasas Road, PMB 665 Calabasas, California 91302-1501

Telephone: [phone] Facsimile: [phone] E-Mail: [e-mail] Contact Person: Mr. Jim England

Date Prepared: April 1, 2004

### Name of Device and Name/Address of Sponsor

FaceMaster Facial Toning System

FaceMaster of Beverly Hills, Inc. 23679 Calabasas Road, PMB 665 Calabasas, CA 91302-1501

### Common or Usual Name

FaceMaster Facial Toning System

#### Classification Name

Transcutaneous Electrical Nerve Stimulator (21 C.F.R. § 882,5890)

#### Predicate Devices

Salton, Inc.'s Rejuvenique® Facial Toning System, Model RJV-10

#### Intended Use / Indications for Use

The FaceMaster Facial Toning System ("FaceMaster System") is intended to stimulate the face. The device is indicated for cosmetic use.

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The FaceMaster System is a transcutaneous electrical stimulator that incorporates a control module and two electrodes on separate, handheld probes to deliver electrical stimulation to the face muscles. The device is prepared for use by laying it flat on a table, opening the control module cover and removing the probes from their cradles inside the control module. Conductive solution is dispensed into a basin within the control module and, after placing the foam pads over the distal end of each probe the pads are soaked in the solution until they are moist. The user then pushes the power (ON/OFF) button to turn the device on and follows the instructions for use and the LCD and audible prompts from the control module to complete the three cosmetic stimulation modes, i.e., the eye cycle, the facial cycle, and the feathering cycle.

### Performance Data

The FaceMaster Facial Toning System complies with FDA's performance standard for electrode lead wires and patient cables set forth in 21 C.F.R. § 898.12. A clinical study of the FaceMaster System, which included testing both with trained observers and self-assessments, was completed to demonstrate the substantial equivalence of the FaceMaster System to other transcutaneous electrical nerve stimulator devices for OTC cosmetic use.

#### Substantial Equivalence

The FaceMaster System is substantially equivalent to other legally marketed transcutaneous electrical nerve stimulator devices for cosmetic use. Specifically, the FaceMaster System is substantially equivalent to Salton, Inc.'s Rejuvenique® Facial Toning System ("Rejuvenique" or the "predicate device"). The FaceMaster System has the same intended use and the same indication for use as the Rejuvenique. The device also has similar technological characteristics as its predicate device. Minor differences in the technological characteristics of the FaceMaster System and the Rejuvenique do not raise any new issues of safety or effectiveness. Thus, the FaceMaster System is substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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JUN 1 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FaceMaster of Beverly Hills, Inc. c/o C. Stephen Lawrence Hogan & Hartson, L.L.P. 2603 Main Street, Suite 1170 Irvine, California 92614

Re: K040871

Trade/Device Name: FaceMaster Facial Toning System Regulation Number: 21 CFR 882.5850 Regulation Name: Transcutaneous Electrical Stimulator for Cosmetic Use Regulatory Class: Class II Product Code: NFO Dated: March 1, 2005 Received: March 3, 2005

Dear Mr. Lawrence:

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.

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Page 2 - Mr. C. Stephen Lawrence

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin mailies of substantial equivalence of your device to a legally premarket notincation. The President of eaching of evice 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 If you desire specific acries ion 7542 240) 276-0120. Also, please note the regulation entitled, Connact the Office of Complains on (xet notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or Manufacturers, International and Octoss <http://www.fda.gov/cdrh/industry/support/index.html>.

Sincerely yours,

Styet Klude
Miriam C. Provost, Ph.D.

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name:

FaceMaster® Facial Toning System

Indications for Use:

The FaceMaster® Facial Toning System is intended to stimulate the face. The device is indicated for cosmetic use.

Prescription Use _ (Per 21 C.F.R. 801.109) OR

Over-The-Counter Use_X_

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Styet Clurdu

(Division Si on-Off Division of General, Restorative, and Neurological Devices

510(k) Number K040871

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