FDA 510(k) Application Details - K231894

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K231894
Device Name	Powered Laser Surgical Instrument
Applicant	Shenzhenshi Sincoheren S&T Development Co.,Ltd. Floor 4,No.2 Plant,No.14 Zhongxing Road,Xiuxin Community, Kengzi Street Office,Pingshan District Shenzhen 518118 CN Other 510(k) Applications for this Company
Contact	Zhongzhou Li 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	06/28/2023
Decision Date	09/20/2023
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