FDA 510(k) Application Details - K223700

Device Classification Name	Device,Analysis,Anterior Segment   More FDA Info for this Device
510(K) Number	K223700
Device Name	Device,Analysis,Anterior Segment
Applicant	Intelon Optics, Inc. 331 Montvale Avenue Floor 5 Woburn, MA 01801 US Other 510(k) Applications for this Company
Contact	Pavana Mysore Ganesh Other 510(k) Applications for this Contact
Regulation Number	886.1850   More FDA Info for this Regulation Number
Classification Product Code	MXK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/12/2022
Decision Date	08/16/2024
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	N
Expedited Review