FDA 510(k) Application Details - K210119

Device Classification Name	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect   More FDA Info for this Device
510(K) Number	K210119
Device Name	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Applicant	Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd RM202-203, Y2 Building, Chuangyi Park, Bantian Town, Long Gang District Shenzhen CN Other 510(k) Applications for this Company
Contact	Cheryl Yang Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	ONF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/19/2021
Decision Date	05/21/2021
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