FDA 510(k) Application Details - K191611

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K191611
Device Name	Powered Laser Surgical Instrument
Applicant	Wingderm Electro-Optics Ltd. Room 312, Building D-3, Dongsheng Science Park, No.66 of Xixiaokou Road Beijing 100192 CN Other 510(k) Applications for this Company
Contact	Juan Zhou 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	06/17/2019
Decision Date	07/31/2019
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