FDA 510(k) Application Details - K191154

Device Classification Name	Laser, Comb, Hair   More FDA Info for this Device
510(K) Number	K191154
Device Name	Laser, Comb, Hair
Applicant	Wontech 64 Techno 8-ro, Yuseong-gu Daejeon 305-500 KR Other 510(k) Applications for this Company
Contact	Gyuri (Erin) Park 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	05/01/2019
Decision Date	07/29/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review