FDA is modernizing its 510(k) program and one change it is mulling is placing a limit on how old a predicate device is when manufacturers ... system got pre-market approval Friday afternoon.

Outside of London, Skinpen is an FDA approved microneedling treatment that ... The issue with at-home devices, says Fatma Shaheen, is that you can’t control the usage and if the device is ...

One particularly interesting new device that just gained FDA approval is a historic milestone, being the very first treatment device that uses shock waves to promote healing. Sanuwave’s ...

This course includes hands-on practice using FDA-cleared microneedling devices under the direct supervision of experienced LexRx NP Clinical Aesthetics professionals. Describe the layers of the skin ...