FDA 510(k) Application Details - K173700

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K173700
Device Name	Powered Laser Surgical Instrument
Applicant	Lutronic Corporation Lutronic Center, 219, Sowon-ro Deogyang-gu, Goyang-si 410220 KR Other 510(k) Applications for this Company
Contact	Jhung Won Vojir Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	GEX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/04/2017
Decision Date	06/19/2018
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