FDA 510(k) Application Details - K230268

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K230268
Device Name	Powered Laser Surgical Instrument
Applicant	Bluecore Company Co Ltd Ace Hightech 21 #1203 48, Centurm Jungang-ro, Haeundae-gu Busan 48059 KR Other 510(k) Applications for this Company
Contact	Bill 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	01/31/2023
Decision Date	08/10/2023
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