FDA 510(k) Application Details - K240644

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K240644
Device Name	Powered Laser Surgical Instrument
Applicant	Wuhan Pioon Technology Co.,Ltd. 7th Floor,A21 of Sino Pharm Building, Biolake Innovation Park,No.666 Gaoxin Avenue,East Lake High-tech Development Wuhan 430075 CN Other 510(k) Applications for this Company
Contact	Feng Zhang 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	03/07/2024
Decision Date	06/10/2024
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