FDA 510(k) Application Details - K233018

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K233018
Device Name	Powered Laser Surgical Instrument
Applicant	IDS, Ltd. RM.908, SJ Techno Ville 278, Beotkkot-ro Seoul 08511 KR Other 510(k) Applications for this Company
Contact	Kwang Yeong Ahn 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	12/21/2023
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