FDA 510(k) Application Details - K250936

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K250936
Device Name	Powered Laser Surgical Instrument
Applicant	Beijing Sano Laser S&T Development Co.,Ltd Room 7-201,No.1,Caida 3rd Street,Nancai Town Shunyi District Beijing CN Other 510(k) Applications for this Company
Contact	Zhu Qi 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	03/28/2025
Decision Date	06/12/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review