FDA 510(k) Application Details - K233007

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K233007
Device Name	Powered Laser Surgical Instrument
Applicant	AMI Inc. RM. 1412, SJ Techno Ville, 278, Beotkkot-ro, Geumcheon-gu Seoul 08511 KR Other 510(k) Applications for this Company
Contact	Hae Lee Youn 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	09/22/2023
Decision Date	06/12/2024
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