FDA 510(k) Application Details - K200667

Device Classification Name	More FDA Info for this Device
510(K) Number	K200667
Device Name	EyeArt
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	03/13/2020
Decision Date	08/03/2020
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