FDA 510(k) Application Details - K251031

Device Classification Name	Powered Laser Surgical Instrument With Microbeam\Fractional Output   More FDA Info for this Device
510(K) Number	K251031
Device Name	Powered Laser Surgical Instrument With Microbeam\Fractional Output
Applicant	Shanghai Apolo Medical Technology Co., Ltd. Building 11, Lane 1566, Nanle Road, Songjiang District Shanghai 201613 CN Other 510(k) Applications for this Company
Contact	Felix Li Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	ONG 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