FDA 510(k) Application Details - K222484

Device Classification Name	Monitor, Eye Movement   More FDA Info for this Device
510(K) Number	K222484
Device Name	Monitor, Eye Movement
Applicant	C. Light Technologies, Inc. 84 High Street, Suite 303 Medford, MA 02155 US Other 510(k) Applications for this Company
Contact	Christy K Sheehy-Bensinger Other 510(k) Applications for this Contact
Regulation Number	886.1510   More FDA Info for this Regulation Number
Classification Product Code	HLL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/17/2022
Decision Date	05/09/2023
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