FDA 510(k) Application Details - K182741

Device Classification Name	More FDA Info for this Device
510(K) Number	K182741
Device Name	SculpSure
Applicant	Cynosure 5 Carlisle Road Westford, MA 01886 US Other 510(k) Applications for this Company
Contact	Amy Tannenbaum 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	09/28/2018
Decision Date	01/03/2019
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