FDA 510(k) Application Details - K192585

Device Classification Name	Laser, Comb, Hair   More FDA Info for this Device
510(K) Number	K192585
Device Name	Laser, Comb, Hair
Applicant	PJM Worldwide, LLC d/b/a Phoenix Medical Technology, LLC 1499 NW 79th Avenue Miami, FL 33126 US Other 510(k) Applications for this Company
Contact	Ira Nusbaum Other 510(k) Applications for this Contact
Regulation Number	890.5500   More FDA Info for this Regulation Number
Classification Product Code	OAP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/19/2019
Decision Date	01/29/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review