SkinPen Precision System

Powered Microneedle Device

Crown Aesthetics

The following data is part of a premarket notification filed by Crown Aesthetics with the FDA for Skinpen Precision System.

Pre-market Notification Details

Device IDK202243
510k NumberK202243
Device Name:SkinPen Precision System
ClassificationPowered Microneedle Device
Applicant Crown Aesthetics 5005 Lyndon B. Johnson Frwy., Suite 370 Dallas,  TX  75244
ContactMarie Fogartie
CorrespondentMarie Fogartie
Crown Aesthetics 5005 Lyndon B. Johnson Frwy., Suite 370 Dallas,  TX  75244
Product CodeQAI  
CFR Regulation Number878.4430 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-10
Decision Date2021-04-02

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