FDA 510(k) Application Details - K223357

Device Classification Name	More FDA Info for this Device
510(K) Number	K223357
Device Name	EyeArt v2.2.0
Applicant	Eyenuk, Inc. 5850 Canoga Ave, Suite 250 Los Angeles, CA 91367 US Other 510(k) Applications for this Company
Contact	Kaushal Solanki Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PIB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/02/2022
Decision Date	06/16/2023
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	N
Expedited Review