FDA 510(k) Application Details - K202243

Device Classification Name	More FDA Info for this Device
510(K) Number	K202243
Device Name	SkinPen Precision System
Applicant	Crown Aesthetics 5005 Lyndon B. Johnson Frwy., Suite 370 Dallas, TX 75244 US Other 510(k) Applications for this Company
Contact	Marie Fogartie Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QAI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/10/2020
Decision Date	04/02/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review