FDA 510(k) Application Details - K243819

Device Classification Name	More FDA Info for this Device
510(K) Number	K243819
Device Name	Luminopia
Applicant	Luminopia, Inc. 955 Massachusetts Ave #335 Cambridge, MA 02139 US Other 510(k) Applications for this Company
Contact	Scott Xiao 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	12/12/2024
Decision Date	04/09/2025
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