GENUINE DERMAROLLER™ THERAPY™
FREQUENTLY ASKED QUESTIONS

• Why should I use a trained practitioner and an authorised Genuine Dermaroller™ Clinic?
• Is the Dermaroller™ a CE marked medical device and are any of the alternative skin needle-rollers CE marked?
• Some skin needle rollers claim to be FDA approved and/ or registered, some even have the FDA logo on the pack and websites, does this mean they have a similar seal of quality and external validation and approval that the Genuine Dermaroller™ CE marking and European medical device certificates provide?

Why should I use a trained practitioner and an authorised Genuine Dermaroller™ Clinic?

The Dermaroller™ medical devices are designed to be used by trained medical practitioners and their clinics in a procedure that will create approx 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 approx 6 weeks apart, this will always be done under consultation and agreement with your medical aesthetic clinic. To see and read some of the results that can be achieved check out the treatment results page and the What the Practitioners and Patients say page on this website.

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™ if you are in doubt please contact us by email or Freephone 0800 0195 322 and we can advise.

If you do not see the Dermaroller^® logo on the outer packaging of the device then it is not a Genuine Dermaroller™ medical device, trained and approved Genuine Dermaroller™ medical professionals and clinics only use Genuine Dermaroller™ medical devices, we do not supply to any body else. Also please remember Genuine Dermaroller™ medical devices are sterile single-use, so your safety will never be compromised by a device that has been stored and re-used.



Is the Dermaroller™ a CE marked medical device and are any of the alternative skin needle-rollers CE marked?

To supply a medical device in the UK and the rest of the European Union the manufacturer must comply with the European Medical Device Directive MDD 93/42 EEU. To supply a sterile medical device the manufacturer and the manufacturing process must be inspected, audited and certified by a notified body and be able to provide a Certificate of Conformity issued by the notified body and the packaging must carry a CE mark accompanied by the notified body unique number which can be easily checked and verified.

Dermaroller™ Class IIa sterile single use medical devices comply with the European Medical Device Directive. They have a Certificate of Conformity issued by MedCert, Germany, are accordingly CE marked and their manufacturing process is certified according to ISO13485, the medical device manufacturing standard. Regulatory compliance of the devices and the manufacturing process are your assurance of quality. The Genuine Dermaroller™ meets this standard - do not accept substitutes.



Some skin needle rollers claim to be FDA approved and/ or registered, some even have the FDA logo on the pack and websites, does this mean they have a similar seal of quality and external validation and approval that the Genuine Dermaroller™ CE marking and European medical device certificates provide?

Compliance with the regulatory standards conveys assurance of quality and safety profile. It must be for this reason that a number of the needle-rollers, their distributors and re-sellers claim "FDA approval" or "FDA registration" and have the FDA logo printed on the packaging, literature or websites. Unfortunately none of the rollers can claim to have FDA clearance and can not state that they are "FDA approved", "FDA registered" or use the FDA logo. As you may be aware some of them do and this is mis-branding. Skin-needle rollers that currently make themselves available in the USA have found a way of doing so by self-classifying as a Class 1 Device described as a ‘manual surgical instrument for general use’ and as such should make no therapeutic claims.

Accordingly, under FDA 21 CFR878.4800, devices that fall in to this category are exempt from the FDA 510(k) pre-market notification requirements and it is only necessary to register the establishment and the device with the FDA on their website prior to sale. This is purely an administrative process and it does not permit use of the FDA logo or convey assurance of quality or approval.

To quote the FDA 21 CFR807.39;

Furthermore you will find the following statement on the FDA website;




If your question is not answered here, please call us on Freephone 0800 0195 322 or email us.