FDA 510(k) Application Details - K240658

Device Classification Name	More FDA Info for this Device
510(K) Number	K240658
Device Name	1060nm laser body slimming machine
Applicant	HeBei JT Medical Co., Ltd. C12 Hegu Industrial Park, Chaoyang Road, Development Zone ZhuoZhou city Hebei CN Other 510(k) Applications for this Company
Contact	Karen Liu 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	03/08/2024
Decision Date	05/13/2024
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