4 results
·
48ms
·
Sources: EU EUDAMED, US FDA
DERMAPEN (MICRONEEDLING DEVICE)
FDA Adverse Event
Injury
·DERMA PEN, LLC.·Product code QAI·May 14, 2025
PRX-T33 (MICRONEEDLING DEVICE)
FDA Adverse Event
Injury
·DERMA PEN, LLC.·Product code QAI·May 14, 2025
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.
FDA Recall
Terminated
·Derma Pen, LLC·Product code PIU·February 5, 2015
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.
FDA Enforcement
Class II
·Terminated·Derma Pen, LLC·September 16, 2015