FDA
DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for dermabrasive use. Each motorized handpiece is packaged within a small box. Each disposable needle cartridge is packaged individually and then placed into boxes of 30 quantities per box.
Derma Pen initiated a field communication for Dermapen after receiving an FDA warning letter for distributing a device without FDA clearance or approval.
Derma Pen sent a notification letter to its customers on February 5, 2015. The purpose of the notification was to inform customers that the FDA issued a warning letter and the steps Derma Pen was taking to address the FDA' s concerns.
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