FDA 510(k) Application Details - K243591

Device Classification Name	More FDA Info for this Device
510(K) Number	K243591
Device Name	OPTOVISION Endoscopic Light Source Unit
Applicant	Optosurgical LLC 6751 Columbia Gateway Dr, Suite 300 Office 313 Columbia, MD 21046 US Other 510(k) Applications for this Company
Contact	Yoseph Kim Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/20/2024
Decision Date	02/19/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review