FDA 510(k) Application Details - K221214

Device Classification Name	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect   More FDA Info for this Device
510(K) Number	K221214
Device Name	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Applicant	Shenzhen IONKA Medical Technology Co., Ltd. Room 601, No. 3, Jiazitang Second Industrial Zone, Fenghuang Street, Guangming District Shenzhen 518123 CN Other 510(k) Applications for this Company
Contact	Chen Dongfa 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	04/27/2022
Decision Date	09/21/2022
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