FDA 510(k) Application Details - K212478

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K212478
Device Name	Powered Laser Surgical Instrument
Applicant	Beijing Stelle Laser Technology Co., Ltd. Rm.502-1, Tower B, Building 1, Yard 26, Zhongguancun Medical Device Park, Yongwang West Rd. Beijing 102600 CN Other 510(k) Applications for this Company
Contact	Zhao Changcheng 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	08/09/2021
Decision Date	01/14/2022
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