What makes cosmetic and medical microneedling device different?
There is a difference between medical devices and cosmetic devices – especially when it comes to skin rejuvenation treatments.
Potential patients must understand the key differences between available devices and treatments, and the variants that separate devices.
Previously, the FDA issued a warning aimed at cosmetic device manufacturers and distributors regarding market claims and clearance when compared to medical devices.
The 2015 warning stated that there should always be clearly defined definitions that were not the same as those used for medical devices. Cosmetic and medical devices are subject to different regulations.
In today’s blog, we’ll be looking at how these differences affect skin rejuvenation devices like those used for micro-needling and the like.
What qualifies a medical device?
Medical devices are recognised as an instrument, machine or apparatus, amongst other things, and are specifically designed to affect the structure of the body, including the skin.
Cosmetic devices cannot guarantee a change to the skin’s physiology, for example, and therefore will not be classified in the same way as a medical device.
Using the different devices for micro-needling
Most obviously, cosmetic and medical micro-needling devices are not mutually exclusive.
While there are some cosmetic micro-needling devices available for at-home use, like dermarollers, medical micro-needling devices like SkinPen can only be operated by qualified and trained professionals.
Dermarollers often classed as cosmetic devices, use wheels of needles. Contrastingly, micro-needling pens rely on a cluster of fine needles at the tip. Both devices work by causing a controlled injury to the skin, which in turn stimulates the growth of new collagen and elastin.
They may sound similar, but the classification of cosmetic or medical is something that should be observed.
Defining medical micro-needling
- Micro-needling offers a safe and chemical free way to trigger new collagen production.
- Medical micro-needling devices are used in the clinic only – they are not eligible for home use.
- The device goes deeper than any cosmetic device available, with a depth of greater than 0.25 mm (SkinPen) maximum depth of 2.5mm, on any part of the body.
- Medical micro-needling devices can only be operated by a qualified and trained professional.
Choosing a medical device like SkinPen
SkinPen is an FDA cleared mechanical micro-needling device, offered in clinics across the UK and distributed by BioActiveAesthetics. The pen is motorised and allows precise control of the needle depth, from 0.25 to 2.5mm. You can read more about the device specified on the website.
Ask us for more information.
Medical micro-needling is widely used for treating acne scars, fine lines and wrinkles, stretch marks, melasma and more. The face, neck, and chest are the most treated areas, although SkinPen can be used all over the body if required.
BioActiveAesthetics is the UK distributor for SkinPen. If you would like more information about the device or how medical micro-needling treatments can improve the skin, please contact us via email or phone.