FDA 510(k), K220506, SkinPen Precision System

FDA 510(k), K220506, SkinPen Precision System

Regular price $89.00 USD
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510(K) Number: K220506
Device Name: SkinPen Precision System
Manufacturer: Marie Fogartie
Device Classification Name: Powered Microneedle Device
Regulation Number: QAI
Classification Product Code: KXA
Date Received: 02/22/2022
Decision Date: 03/07/2022
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.

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