FDA 510(k) Application Details - K181019

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K181019
Device Name	Powered Laser Surgical Instrument
Applicant	Guangzhou Huafei Tongda Technology Co., Ltd. 4/F, Building B Industrial and Commercial Trading Park, Hainan Town Huadi Dadao Nan Road, Fangcun, Liwan Dis 510388 CN Other 510(k) Applications for this Company
Contact	Liu Pengqi 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	04/17/2018
Decision Date	07/16/2018
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