FDA 510(k) Application Details - K214015

Device Classification Name	More FDA Info for this Device
510(K) Number	K214015
Device Name	Palm NRG cellulite body device (model: Palm NRG body device)
Applicant	Heat In A Click LLC. 1975 Tigertail Blvd Dania, FL 33004 US Other 510(k) Applications for this Company
Contact	Guy Levi Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PBX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/22/2021
Decision Date	09/26/2022
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