FDA 510(k) Application Details - K221872

Device Classification Name	Endoilluminator   More FDA Info for this Device
510(K) Number	K221872
Device Name	Endoilluminator
Applicant	Nova Eye Inc. (Business name Nova Eye Medical) 41316 Christy St. Fremont, CA 94538 US Other 510(k) Applications for this Company
Contact	Don Watton Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	MPA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/28/2022
Decision Date	03/30/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review