FDA 510(k) Application Details - K233307

Device Classification Name	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect   More FDA Info for this Device
510(K) Number	K233307
Device Name	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Applicant	Beijing ADSS Development Co., Ltd. Room 609, F6, Building 13, Yard 5 Tianhua Street, Daxing District, Beijing 102600 CN Other 510(k) Applications for this Company
Contact	Jijuan Wang 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	09/29/2023
Decision Date	03/15/2024
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