Medical micro-needling device needle length ranges from 0.5 mm up to 2.5 mm. These devices penetrate deeply into the skin. Therefore, if you believe this commonly made claim by other micro-needling manufacturing firms and online resellers, and if you don’t care about your health and safety, then the answer would be yes. The claim could possibly be true if the devices were entirely made of metal. If so, then the rollers could be re-sterilized. However, that is not the case. All medical micro-needling devices have a plastic roller into which metal micro-needles are embedded. They are designed to be disposable. It is critical that medical micro-needles, regardless of length, be maintained sterile before a procedure for your safety and to comply with FDA regulations. After each use, the needles dull and may loosen. The needles CAN’T be re-sharpened after use. Reusing these damaged needles will require more force to penetrate and may tear the skin. This leads to greater pain, tissue damage, potential nerve damage and infection, and less than optimal results. A surgeon would never reuse a disposable surgical device. By doing so, he invites a poor outcome and potential problems. So, why would you?
Only the home rollers are designed so that they can be reused safely. Since the micro-needles in the home rollers do not penetrate as deeply as the medical micro-needling devices, the needles are easily cleaned by using a non-irritating cleaning solution.
Only home rollers with a needle length of 0.2 mm or less can be cleaned and reused. The FDA has established clear guidelines and standards with public safety in mind. Micro-needling devices that have needles longer than .03 mm begin to reach blood vessels thus making you subject to infection. All medical/surgical devices with needle lengths of 0.5 mm or greater have to be sterile prior to their use. This same standard applies to all medical/surgical disposable devices. Consider, if it is important for a device to be sterile prior to a procedure then it is equally important that it remain sterile if it is to be reused. An apparent double standard, don’t you think? We do NOT recommend re-sterilizing a disposable product. Alcohol or similar solutions do NOT sterilize. Autoclaves use heat and will deform the plastic. The roller and its needles are therefore ruined. This increases the risk of infection, injury and pain during a procedure.
Consider that your skin at its deepest thickness is 2.5 mm. Most other roller manufacturing companies sell rollers with 3 mm needles in length for one obvious reason. They need to sell longer needles in order to achieve adequate skin penetration because their needles are blunt and poorly designed. Therefore, more force needs to be applied in order to penetrate the skin increasing trauma to the skin and the risk of injury. We are sure that many of you have observed videos in YouTube and elsewhere where micro-needling procedures using other manufacturers devices are shown. These videos may have given many of you cause for concern. Their needles lack in engineering quality and design, and most importantly, sharpness. In contrast, if a Dermaroller® micro-needling device were to be used, you would obtain the same results with a roller that has 1.5 mm needles or less in length with minimal trauma.
In order to respond to the claim that more needles are better the “Fakir Effect” will be explained. Many have witnessed or seen pictures of a Muslin or Hindu religious man laying on a bed of nails. This man is called a Fakir. Then, as he lays on the bed of nails, either a heavy cement block is placed on his abdomen or someone stands on his belly. Miraculously, no nails penetrate the skin of the holy man. How is this possible? Why don’t the needles penetrate and severely injury the man? The answer lies in the number of needles that were imbedded in the bed of nails. The greater the number of nails, the more force is required for the nails to be able to penetrate the skin. With a large number of nails his weight becomes evenly distributed amongst the nails, therefore it becomes difficult for any one nail to penetrate the skin because there is not enough force one any one nail to drive the nail through the skin. However, if the number of nails is reduced significantly, the weight becomes distributed amongst a lesser number of nails. There will be more force or weight on each nail, and they will penetrate the skin.
In short, more micro-needles in a roller only means that significantly greater force will have to applied onto the skin in order for the micro-needles to begin to penetrate the skin. More needles only serve to make a roller inefficient. The risk of injury increases. Medical Dermaroller® devices have the appropriate number of micro-needles to be effective. This is another good reason for choosing Dermaroller® engineered medical devices.
The engineering and design of a micro-needle is one of the most important elements. Not all micro-needles are manufactured the same. In addition to the risks associated with weak standard steel or acupuncture needles, these needles also cut and tear holes in the skin. This creates real wounds hindering and altering proper cell regeneration. Dermaroller® contains the best surgical grade needle engineering design in the industry. It contains specific alloys to achieve maximum cell regeneration while creating the smallest skin puncture possible.
In most cases, a thinner needle simply means a weaker needle. They’ll just buckle and bend more easily during a CIT procedure. A thin needle is necessary, but it’s only safe to use when it can sustain and bear a force of at least 2,000 Newtons (1 Newton = 1 kg·m/s²). Very simply, the needles have to be very strong and sharp.
After every medical micro-needling procedure time is required for the body to naturally allow collagen to mature. Performing a CIT procedure any more frequently than every 6-8 weeks is counterproductive. Contrary to other manufacturers, we recommend waiting at least 6-8 weeks between each procedure. Sometimes more time is needed depending on the condition being treated. This waiting period allows for the maturation of the repair and regenerative process to complete its cycle. Repeating the procedure sooner than six to eight weeks in between provides no additional clinical benefit. It only invites additional trauma and unnecessary costs.
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.
Collagen Induction Therapy is a medical procedure. A Dermaroller® medical procedure should be performed by a trained medical professional in order to obtain maximal results. Don’t be deceived by other manufacturers into believing that you can get the same results as a trained medical professional by doing it yourself. If you are considering or have had CIT or have attempted to perform CIT yourself, consult a medical professional.
Medical micro-needling is regarded as a medical procedure worldwide because it reaches deep into the dermis. It can cause damage when performed incorrectly. This is why CIT or medical micro-needling is a medical procedure. If you were undergoing a surgical procedure, wouldn’t you want to make sure the practitioner knows how to do it correctly? There is more to CIT than simply needling the skin. This is why we protect patients by selling Medical Dermarollers® only to medical professionals and by providing Certified Dermaroller® training.
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.
In order to be able to distribute a medical device in either the United Kingdom or in the European Union (EU) member countries, a manufacturer must comply with the European Medical Directive MDD 93/42 EEU.
Before a sterile medical device can be distributed the manufacturer and the manufacturing process must be inspected, audited and certified by a Notified Body. A Notified Body is nominated by the EU and its main function is to assure that all manufacturers of medical devices conform to EU Medical Directives. If a manufacturer conforms then it can bear the CE Marking which means that the manufacturer has complied with all of the essential requirements listed in each Medical Directive. A Certificate of Conformity is then issued to the manufacturer by the Notified Body and the packaging must bear a CE mark accompanied by the Notified Body unique number which can be easily checked and verified.
Dermaroller® medical devices are classified as a Class II in Europe (Class I in the US). Our sterile single use medical devices are the only sterile skin-needle rollers in the world that comply with the European Medical Device Directive MD 93/42 EEU. Dermaroller® has earned a Certificate of Conformity issued by MedCert, Germany. Our manufacturing process is certified according to ISO 13485, the medical device manufacturing standard, and our products bear the CE mark.
Regulatory compliance of the manufacturer, manufacturing process and the quality of the devices are your assurance of safety and quality. Only the Genuine Dermaroller® meets this standard – do not accept substitutes.
Note: As you do your online investigation, you will be advised by other sites and manufacturers of skin-rollers that the abovementioned facts are meaningless. Be informed, be aware. Ask yourself, why would Dermaroller® go through all the trouble to be certified? The answer is simple. We comply with the laws and standards of the US, Europe and Australia. It considers your safety and well being paramount.
The Dermaroller® medical devices are designed to be used by trained medical practitioners and their clinics in a procedure that will create approximately 300 micro medical needle channels per cm² in to the dermis of the skin. Below the outer stratum corneum layer of the epidermis the needle is penetrating in to living tissue. In the dermis, the target area of Genuine Dermaroller™ Therapy™, there is a complex of epithelial cells, blood supply, nerve cells, extracellular matrix, collagen, elastin and cells such as fibroblasts that produce and repair this essential part of our bodies. By providing a controlled physical stimulation of the dermis your practitioner is able to initiate a natural skin regeneration and repair process that can lead to smoother, brighter, healthier, younger looking skin and that can help improve and smooth atrophic scaring caused by diseases such as acne and chicken pox, and injury. To achieve the desired results it is often necessary to carry out 3 procedures approximately 6 weeks apart, this will always be done under consultation and agreement with your medical aesthetic clinic.
But don’t get fooled in to thinking that skin-needling is a procedure you should do yourself at home, no matter what some of the non-medical device needle roller re-sellers and websites say. For an effective treatment your practitioner will be looking to achieve pin-point bleeding, uniform redness and slight swelling across the treatment area. The Genuine Dermaroller™ Therapy™ will however be comfortable, a topical anaesthetic will be applied (this should only be used under medical supervision), this “numbing” effect along with the quality of the device and the technique of the trained practitioner will make the procedure a pleasant experience. Once the Genuine Dermaroller™ Therapy™ procedure has finished and the skin has been cleansed and soothed the treated area will look just like the sunburn we mentioned earlier and will feel warm and tight. Because Genuine Dermaroller™ practitioners have been through thorough training effective treatment can be provided around the delicate mouth area, around the sensitive eye contour and even on the eye-lids, but this should only be done under the care of a trained medical professional within an approved Genuine Dermaroller™ medical aesthetic practice.
The tremendous benefits of Genuine Dermaroller™ Therapy are not only the fantastic clinical results but the excellent safety profile and lack of down-time associated with the procedure. Because the Genuine Dermaroller™ medical device is of such high quality, with precision surgical needles that are incredibly sharp and fine and a medically engineered design (including needle-length), minimal pressure is required to achieve the creation of the multiple skin-needle columns and virtually no unnecessary peripheral damage is caused to the skin. Therefore your practitioner can achieve optimum stimulation of the dermis, whilst keeping the outer layer of the skin the epidermis intact. This reduces the risk of exposure to UV and minimises the “social down time”. Normally after a procedure the skin looks like moderate sun burn that will normally significantly reduce within 12 to 24 hours.
If you think you are a potential candidate for Genuine Dermaroller™ Therapy™ make sure you consult and discuss your needs with a trained and approved Genuine Dermaroller™ Therapy™ practitioner and clinic, initial information can be found on this website on the find a clinic page. Only medical practitioners and clinics that have had their practitioners go through the thorough Genuine Dermaroller™ medical device training can use the Genuine Dermaroller™.
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