FDA Clearance Puts SkinPen on Top | 1Clinic
FDA Clearance Puts SkinPen on Top
Microneedling has come of age in the medical aesthetic arena as SkinPen® from Bellus Medical (Addison, Texas) recently announced that it is the first and only microneedling system to receive a De Novo clearance as a Class II medical device by The Food and Drug Administration (FDA). This designation grants the company clearance and marketing authorization for the device, which is intended to improve the appearance of facial acne scars in adults aged 22 years or older. This clearance was based on the FDA’s recently codified language regarding aesthetic uses of microneedling.
The bottom line for aesthetic practices: SkinPen is the first and only microneedling system to receive this type of clearance.
SkinPen has also set a new technological and safety standard for microneedling, offering minimally invasive, non-ablative options utilizing state-of-the-art skin rejuvenating technology. Employing straight needles that penetrate at a 90° angle, SkinPen creates hundreds of vertical microscopic channels in the dermis to trigger skin remodeling without causing scar tissue formation.
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