FDA 510(k) Application Details - K231394

Device Classification Name	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect   More FDA Info for this Device
510(K) Number	K231394
Device Name	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Applicant	Smedtrum Medical Technology Co., Ltd. 1F., No. 8, Ln. 97, Wugong Rd., New Taipei City 248016 TW Other 510(k) Applications for this Company
Contact	Crimson Wu 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	05/15/2023
Decision Date	08/09/2023
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