FDA 510(k) Application Details - K230340

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K230340
Device Name	Powered Laser Surgical Instrument
Applicant	AMT Engineering Co., Ltd 811-812 Byoksan Technopia 560, Duchon Daero Jungwon gu, SeongNam-si Gyeonggi do 13230 KR Other 510(k) Applications for this Company
Contact	SeoungSoo Choi 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	02/07/2023
Decision Date	05/04/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review