Am I safe even if a micro-needling company claims that it is FDA registered?

Answer: Maybe.

Please note that a Class I medical device, such as a medical micro-needling roller, has to be Registered with the FDA. There is no FDA Approval. But, FDA standards still have to be met.

Most micro-needling companies based in England, Africa, China, Korea and elsewhere are getting away by claiming "FDA Approved" on their packaged products and advertisement in order to market their rollers as being safe and effective. For example, companies based in England are repackaging products to resell to the US public. Most are neither following established FDA standards nor individual state regulations. The US public is unaware of these facts.

Each medical device must be in a sealed clearly labeled container. On each container there must be an indication of the method used in sterilizing the product, the date of production and expiration, lot number and the type of device contained therein. Medical micro-needling started in Europe and is relatively new to the United States. The FDA has not yet set specific micro-needling standards to follow. We are assisting the FDA in establishing micro-needling standards. As an ethical company, Dermaroller® doesn't just stop at being registered with the FDA. It is also registered in the European Union and Australia as Class II devices. It adheres to strict production and safety standards. Patient safety is considered paramount. Click this link to be directed to the FDA website so you can verify if a certain micro-needle device is actually registered with the FDA.

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.