FDA 510(k) Application Details - K233720

Device Classification Name	More FDA Info for this Device
510(K) Number	K233720
Device Name	Luminopia
Applicant	Luminopia, Inc. 955 Massachusetts Ave #335 Cambridge, MA 02139 US Other 510(k) Applications for this Company
Contact	Endri Angjeli Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QQU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/21/2023
Decision Date	08/08/2024
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