FDA 510(k) Application Details - K180511

Device Classification Name	More FDA Info for this Device
510(K) Number	K180511
Device Name	Eon FR
Applicant	Dominion Aesthetic Technologies, Inc. 2431 Aloma Avenue Suite # 225 Winter Park, FL 32792 US Other 510(k) Applications for this Company
Contact	Ahmed Mohammed Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PKT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/27/2018
Decision Date	06/12/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review