FDA 510(k) Application Details - K211735

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K211735
Device Name	Powered Laser Surgical Instrument
Applicant	Zhengzhou Bestview St Co., Ltd. Room 2004, 20F, Lande Center, Huayuan Road, Jinshui District Zhengzhou 450000 CN Other 510(k) Applications for this Company
Contact	Yangchun Jia 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	06/07/2021
Decision Date	10/22/2021
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