FDA 510(k) Application Details - K251049

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K251049
Device Name	Powered Laser Surgical Instrument
Applicant	Micro-Energy Medical Technology Co., Ltd Section B4301, B4701 and B4901, No. 13, Baolan Road Kengzi Street, Pingshan District Shenzhen 518118 CN Other 510(k) Applications for this Company
Contact	Danning Zhu 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	04/03/2025
Decision Date	07/02/2025
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