FDA 510(k) Application Details - K243664

Device Classification Name	Camera, Ophthalmic, Ac-Powered   More FDA Info for this Device
510(K) Number	K243664
Device Name	Camera, Ophthalmic, Ac-Powered
Applicant	AI Optics 145 Lexington Ave Floor 10 New York, NY 10016 US Other 510(k) Applications for this Company
Contact	Andrew DiGiore Other 510(k) Applications for this Contact
Regulation Number	886.1120   More FDA Info for this Regulation Number
Classification Product Code	HKI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/27/2024
Decision Date	12/17/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review