We are writing to you because we have obtained information that has revealed a serious regulatory problem involving a product known as "Dermal Tone," which is marketed by your firm. The Dermal Tone is promoted and sold on the Internet at www. This website material states that "The Dermal Tone is an electronic device which sends out tiny amounts of electricity to designated areas of your face which causes muscles to flex and relax, exercising them for you. Under a United States Federal law, the Federal Food, Drug, and Cosmetic Act Act , the Dermal Tone is considered to be a medical device because it is intended to affect the structure or function of the body. See the above claims for the device. Also, because the Dermal Tone is intended to affect the structure or function of the body by providing electrical current to various facial muscles to repeatedly flex contract them, it is a device, even if no claims were made for its specific use. The law requires that manufacturers of medical devices obtain marketing clearance for their products from the Food and Drug Administration FDA before they may offer them for sale.
Dermal Tone Facial Exercise Treatment
Warning Letter to Dermal Tone, Inc.
I have begun using the Dermal-Tone again faithfully in the past few months. I am now over forty and beginning to take a more assertive approach to skin care. I use the Dermal-Tone Facial Exerciser approximately four times a week and can definitely see a difference in the firmness and lift in my face. I still have good muscle tone in my face, so I use this treatment as more preventative. When using the Dermal-Tone regularly, I do particularly notice a difference in the lift
Dermal-Tone Facial Exercise Treatment
Free shipping. Tested and works. No box or lotion, but I have read that you can use any household lotion as a conductor. Skip to main content. Email to friends Share on Facebook - opens in a new window or tab Share on Twitter - opens in a new window or tab Share on Pinterest - opens in a new window or tab.
The Dermal Tone facial exercise treatment claimed to have anti-aging effects. This portable home machine uses electric pulses to stimulate your aging and sagging facial muscles. The people at Dermal Tone proclaimed that the building of facial muscles as a result of using their machine would tighten your skin, giving it a more youthful appearance.