FDA 510(k) Application Details - K212331

Device Classification Name	More FDA Info for this Device
510(K) Number	K212331
Device Name	BodySculp
Applicant	Rohrer Aesthetics, LLC 105 Citation Court Birmingham, AL 35209 US Other 510(k) Applications for this Company
Contact	Mark Rohrer 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	07/27/2021
Decision Date	11/09/2021
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