FDA 510(k) Application Details - K250656

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K250656
Device Name	Powered Laser Surgical Instrument
Applicant	Wuhan Pioon Technology Co.,Ltd. 12th Floor, Building 1, Innovative Unit, R&D Center Project, Marine World Shipyard Park, No. 16 Fozuling 3rd Road, East L Wuhan 430205 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	03/05/2025
Decision Date	04/04/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review