There are a lot of companies claiming to be FDA Approved. Is Dermaroller® FDA Approved?

Answer: No.

The FDA considers micro-needling devices as a Class I Medical Device. Therefore, companies wanting to market their products in the US can only be FDA Registered. Companies that claim to be certified by using terms such as "FDA Certified" or "FDA Cleared" or "FDA Approved" are making false claims. These are made up certifications. Making any of the claims listed above only serve to alert you that a company is not in compliance with the FDA regulations, is falsely advertising and is perhaps fraudulent. The only factual statement that is allowed to be made is  that a device is indeed “FDA Registered”. All Medical Dermaroller® micro-needling devices are FDA Registered as Class I medical devices. Dermaroller® is compliant with US laws and regulations. Some companies also imprint the FDA logo on their labels, websites, containers or packages. The FDA does not permit the use of their logo. Please see link below to verify this information.

Ask the manufacturer directly if you are uncertain or have questions about their product. Should the manufacturer be US based or if it has a US office, you should be able to obtain answers to all of your questions telephonically. As is usual most disreputable companies hide in the internet by having you rely on email communications. If not, here are some links that may help you answer your concerns. FDA website link that states no company is allowed to use their logos on any advertisements. 

Testimonials
"I chose Dermaroller ® due to it's impecable reputation and widespread use throughout Europe. I have seen Dermaroller ® time and time again win awards for standard of care. "
Ira Lee NP
Dermaroller Practitioner
See More Testimonials >
"As a integrative doctor when I saw what the Dermaroller ® was doing with my patient's energy and the increases blood flow to her face I knew that this was an amazing device. The women that I trained on had major acne scars. "
Jorge Moreno DO
Dermaroller Practitioner
See More Testimonials >
"My client's, co-workers, and myself are amazed and thrilled with my results. "
Maggie Griffith , HairArts Spa
https://dermarollerus.com/sites/default/files/styles/300x424/public/small.jpg?itok=mlb3KitU
"I recommend Dermaroller treatments to my friends all the time. "
Tammy H , Medical Dermaroller Patient
https://dermarollerus.com/sites/default/files/styles/300x424/public/small.jpg?itok=mlb3KitU

Recent News

New York, NY – In recent years, micro-needling roller devices have been appearing everywhere, although many consumers are still unaware of the risks they take by using rollers manufactured in less-than-ideal conditions. Those who... (read more)

Reno, NV - On Thursday, Nov.15, from 6:00 to 8:00 p.m., the Nevada Center for Dermatology will host an open house at their Reno office (650 Sierra Rose Drive, Suite A, Reno, Nevada). The evening will feature Dermaroller... (read more)

Los Angeles, CA - Once again, Dermaroller ® has created a product that leaps ahead of the competition. Now, with eDermaStamp®, Certified Dermaroller Providers are able to mechanically treat patients’ stretch... (read more)

FAQs

"Where do I go to see if a micro-needling company is Registered with the FDA?"
"Am I safe even if a micro-needling company claims that it is FDA registered?"
"Can any one perform medical micro-needling?"
"Can I achieve the same results if I use a micro-needling device at home?"
"There are a lot of companies claiming to be FDA Approved. Is Dermaroller® FDA Approved?"
"If I use my micro-needling device more frequently will I achieve better results?"
"Are thinner needles like acupuncture needles better?"
"Are all micro-needling device needles engineered the same?"
"If a roller has more and longer needles, will I get better results?"
"Can micro-needling devices be cleaned or sterilized for repeated home use?"
"Can a medical micro-needling device be reused?"
"Is the Dermaroller® a CE marked medical device? Are any of the alternative skin needle-rollers CE marked?"
"Why should I use a trained practitioner and an authorized Dermaroller® Clinic?"

Testimonials

I chose Dermaroller ® due to it's impecable reputation and widespread use throughout Europe. I have seen Dermaroller ® time and time again win awards for standard of care.

As a integrative doctor when I saw what the Dermaroller ® was doing with my patient's energy and the increases blood flow to her face I knew that this was an amazing device. The women that I trained on had major acne scars.