Device product
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.
Z-2740-2015
Product summary
- Firm
- Derma Pen, LLC
- Event
- Event 71149
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,466 units
- Official record key
device-enforcement:Z-2740-2015
Official wording
Reason: Derma Pen initiated a field communication for Dermapen after receiving an FDA warning letter for distributing a device without FDA clearance or approval.
Code information: All devices on the market
Distribution pattern: Worldwide Distribution - US (nationwide) Distribution including Puerto Rico and The Virgin Islands and to the countries of : Canada, Brazil, Colombia, Ecuador, Costa Rica, Australia, Hong Kong, Netherlands, Mexico, Romania, Sweden, Peru, Greece, United Kingdom and United Arab Emirates.
Derived failure modes
-
Unknown
Derma Pen initiated a field communication for Dermapen after receiving an FDA warning letter for distributing a device without FDA clearance or approval.