Many of you will be aware from some of our past social media posts and videos that our SkinPen Microneedling device is FDA approved. Its something we are very proud of.
You may also have noticed there are some other devices that are ‘FDA approved’ but did you know there are 3 classes of FDA approval each one more strict than the other. Class I, Class II and Class III. The assignment of a classification for a device depends upon the level of risk that is associated with the device. Many microneedling manufacturers will categorise their device under another heading such as microdermabrasion (despite microneedling and microdermabrasion being two completely different methods) to gain FDA clearance. If the device is catergorised in a ‘less risky’ category it can gain Class I clearance easily.
Class I devices are considered to be at the lowest level of risk of all medical devices and are therefore required to comply with the lowest level of regulatory control. Examples of Class I products/devices include: elastic bandages, dental floss and enemas.
Class II devices are simple devices, though they are more complicated than Class I devices. They are also considered to be at slightly higher risk than Class I devices and therefore require more stringent regulatory controls to provide assurance of their effectiveness and safety. Examples of Class II products/devices include: condoms, pregnancy testing kits and powered wheelchairs.
Class III devices are generally considered to be the most complex devices. They are also considered to be at the highest risk and therefore require more stringent regulatory controls to provide assurance of their effectiveness and safety. Examples of Class III devices include surgical products such as: implantable pacemakers and breast implants.
From these Classes you would imagine most devices used in the aesthetic industry would be required to be Class II or III right? They can cause harm if not regulated correctly right? But did you know some microneedling devices that claim to be FDA approved have been cleared under Class I, this means they haven’t undergone the strict tests that would be required for Class II or III.
Our SkinPen microneedling device has been cleared by the FDA in Class II.