FDA 510(k) Application Details - K250041

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K250041
Device Name	Powered Laser Surgical Instrument
Applicant	Zhengzhou PZ Laser Slim Technology Co., Ltd. Room 201, 2nd Floor, Building 2, No. 52 Hongsong Road High-tech Development Zone Zhengzhou City 450001 CN Other 510(k) Applications for this Company
Contact	Junmei Li 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	01/08/2025
Decision Date	05/14/2025
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