FDA 510(k) Application Details - K182498

Device Classification Name	Powered Laser Surgical Instrument With Microbeam\Fractional Output   More FDA Info for this Device
510(K) Number	K182498
Device Name	Powered Laser Surgical Instrument With Microbeam\Fractional Output
Applicant	Jiangsu Unimed Laser Technology Co., Ltd. 2F, Building D4, No.6, West Dongsheng Road, High-tech District Jiangyin 214000 CN Other 510(k) Applications for this Company
Contact	Simon Wang Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	ONG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/12/2018
Decision Date	11/30/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review