FDA 510(k) Application Details - K240520

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K240520
Device Name	Powered Laser Surgical Instrument
Applicant	Beijing Sea Heart International Science And TechnologyCo.Ltd Room 4009, Building 4, Zhongke Jingwei Industrial Park No.8 Yongchang Middle Road,Economic and Technological Develo Beijing 100176 CN Other 510(k) Applications for this Company
Contact	Xiaoli He 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	02/23/2024
Decision Date	05/20/2024
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