The internet is flooded with cheap roller copies, and when you are interested in them keep always the popular saying in mind:
If you want to pay with peanuts, you should not be surprised when you are served by a monkey.
Innocent consumers are often the targets of ruthless copy pirates. These days more or less everything is forged – from a Rolex, car spare parts to medical devices, and unfortunately this applies also for the Dermaroller™. Curious persons want to buy the ORIGINAL but also want to “save some money” and once they have paid and received the order, it is too late and they are disappointed victims. No doubt, the Internet is a fantastic tool to obtain information, but it is also a platform for pirates. They even have no scruples to misuse protected Trademarks (TM), may it be on their copy products or websites. They sell, abscond and the consumer holds the short end of the stick.
From our point of view to copy a medical device, offer it to the public on Internet platforms and to invite people for self-treatment is a crime. The copiers often claim their product is MADE in XXX, but matter of fact most originate from some backyard outlets. They also claim and imprint on their packing it is FDA approved or CE-marked. All this is totally wrong and actually a criminal act in the USA and European Countries.
“Can I use the FDA logo? The FDA logo should not be used to misrepresent the agency nor to suggest that FDA endorses any private organization, product, or service. Misuse of the FDA logo may violate federal law and subject those responsible to criminal penalties.”
They also claim their product is sterile – but have no validated proof. How can a consumer be sure that this copy was not used before and that it is not contaminated with a dangerous virus? – He or She simply can’t. Even when listed with the FDA this does not mean the device is in accordance with the governmental regulations. Any medical device made or imported in the US must comply with the FDA regulations Part 820. If they don’t they are considered as an adulteration.
We know it is very difficult for a layperson to figure out what is right and what is wrong. And in order to guide you to the ORIGINAL the GENUINE and to bring some light in this jungle, here are some useful hints how to differentiate the copy from the Original.
Never buy a Medical Device Class I or II (needle roller):
When the packing indicates that it is FDA approved or if it carries the FDA logo. If you are in doubt, contact the FDA. Ask the vendor to show you a copy of the approval.
When the packing has no CE-mark followed with a 4-diget number. This 4-diget number indicates the European Notified Body that approved the instrument as a medical device that can be freely traded and is in conformity with the European Regulations, Annex V. Ask the vendor to show such a Certificate of Conformity issued in the name of the manufacturer and where it is registered. If he can’t, it is an illegal device or in many cases this CE-mark is forget.
When the packing carries the imprint GMP. This means Good Manufacturing Practice and is similar to the European ISO 13485 (International Organization of Standardization). Ask the vendor for the GMP Certificate issued in the name of the manufacturer. If you are in doubt ask the FDA.
When the packing indicates that the medical device is sterile and has needles longer than 0.3 mm and can be used several times. Copiers often say that their roller can be sterilized at home by submerging it in alcohol or other detergents. Don’t do it! Alcohol is not a sterilizer, it only can disinfect to a certain extent, but an AIDS virus is not killed.
When you are invited to treat your self with a needle roller, especially when needles are longer than 0.2 mm. Such an invitation you often can read on the vendor’s Internet site. Don’t do it!
Needles, also those of a needle roller, are invasive instruments, and if they are not guaranteed sterile they will transport bacteria into the dermis. This can result in blood poisoning, massive infections with possible and permanent disfigurement of your skin. Therefore any needle roller with needles longer than 0.2 mm is a SINGLE USE DISPOSABLE instrument.
When you buy rollers from the Internet with needles longer than 1.5 mm you risk severe tissue damage, vessel and nerve rupture and nasty haematomas, and more…
Never apply a numbing cream outside a doctor’s office on your skin. Numbing creams, especially those without GMP approval, can lead to a fatal anaphylactic shock.
Copy Pirates never produce any scientific evidence. Their aim is the quick Dollar and a fooled consumer. Copiers only imitate but without engineering knowledge. They often use third class steel, thick and dull needles, and hazardous materials. Don’t get fooled, even these copies have an appealing lock.
LIABILITY. Please keep in mind one very important point: Copiers never hold a liability insurance for their device in case “something happens”. No insurance company will underwrite a risk if the vendor or manufacturer is not GMP or ISO certified.
Don’t be taken in by such trademark infringements spelled and written in various ways such as: dermarollers (with an “s” at the end) derma-roller Dermaroller-planet Scientia Derma Roller MTS Roller Dr-roller and so on. These copiers hardly produce any scientific papers and often steel text and pictures from our website – sad but true.
We invented and patented the Dermaroller in the year 2000. It is a fantastic, simple and most effective instrument for skin improvement and acknowledged by physicians all over the world.
Except the Home Care Dermaroller with its harmless short needles of 0.2 mm, a Dermaroller, especially the medical version, belongs in the hands of a trained and licensed skin care professional. Only the professional has the knowledge of skin anatomy and knows when and how to use the Dermaroller. The treatment of acne scars or stretch marks is far less expensive than other ablative procedures. Please, contact a physician and never treat yourself! All medical Dermarollers are SINGLE USE DISPOSABLE instruments that must be disposed after use according to regulations!
Our Engineering Company Dermaroller S.a.r.l., based in Germany, manufactures the ORIGINAL, the GENUINE Dermaroller. We are the only company worldwide that produces the Dermaroller according to ISO 13485, the international standard for Medical Devices. (See our certificate of Conformity below). It was our company that has initiated many medical articles, case studies and findings in cooperation with various Universities, Clinics and Physicians worldwide. Because your skin is our concern and for many good reasons we never sell medical devices to laypersons, only to physicians via our international affiliated distributors.
If you love your skin and in case it should be treated to the better, look for professional help. And if you are in doubt or if you have a question we’ll always be strived to give you an honest answer.
Yours Sincerely
The Dermaroller Team
Dear Dermaroller Team:
After reading the information on your website I am confused. There are several distributors of dermaroller type devices in the USA but only two official distributors for the original Dermaroller. Yours comes from Germany and the others either from England, China or Korea or perhaps are manufactured elsewhere.
To a consumer the other dermaroller type devices appear to be the same. After looking at the other respective websites they make what would be considered legitimate claims about their products. You say their quality and standards and claims are false.
The Dermaroller had to be registered in the USA with the FDA etc. in order to qualify as medical devices. Don’t the other dermaroller type devices in the USA have to also register with the FDA and subject to their oversight just as yours is? How does this occur and why hasn’t the FDA taken action? What set of facts am I missing?
I am concerned about my health and safety. Can you please clarify these issues for the consumer.
Sincerely,
Tony
Dear Tony,
Let me try to clarify your confusion, and also note that this is not an official legal advice.
If someone, a company or a person, has a protected name it is called Trademark®. Once your Trademark or Trade name is registered and approved this is indicated with an affix ™ or ® at the end of the Trademark and is the intellectual property of the registrant. Therefore no third party may use this term on his brand. If a third party uses the Trademark without permission this is an infringement and a criminal act and subject to legal claims. http://www.uspto.gov/web/offices/tac/tmlaw2.pdf
So don’t get confused and simply follow our distributor list then you’ll be always on the right track and you are sure to buy the ORIGINAL that follows the “rules” set in force by the law.
Any person or enterprise that registers a Medical Device (MD) with the FDA in the US or with so called Notified Bodies in Europe MUST fulfil certain requirements BEFORE the registration. If a registrant does not apply with theses rules, regulations, directives and laws the MD is considered as an adulteration, and the registrant must face all consequences. These regulations can be found:
For the US: http://google2.fda.gov/search?q=Part+820&x=0&y=0&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&output=xml_no_dtd&getfields=*
For Europe:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31993L0042:EN:HTML
As these governmental bodies are flooded with registrations it is virtually impossible for them to check if each applicant has fulfilled all his obligations. Therefore it is unlikely that such a huge body like the FDA acts on his own. It is the applicant’s duty to comply with the rules! If not he must face the consequences and possible punishment by impinging against the respective laws.
To make it easier to understand, here is a simple example: You are obliged by law to carry all your identification papers with you when driving a car, such as ID-card, car registration, insurance, etc. If a police officer catches you – more or less accidentally – without the papers, that clearly prove that you are entitled to drive this car, you have to face the consequences and pay a fine – as a minimum. The same will happen to manufacturers of medical devices that are not in accordance with the regulations.
It is a sad affair that many infringers try to get around the law and deliberately hazard the health consequences of their customers. Unfortunately the Internet is a huge platform where these people can hide – but only for a short while. In the end they must face the consequences. We have filed complaints to the FDA but it takes some time until they act. If you and many others feel fooled by these trademark pirates and Medical device adulterators, please write your own complaint http://www.fda.gov we are sure the FDA takes it serious.
Best regards
Your Dermaroller Team