FDA 510(k) Application Details - K172645

Device Classification Name	More FDA Info for this Device
510(K) Number	K172645
Device Name	iLux Instrument, iLux Disposable
Applicant	Tear Film Innovations, Inc. 12625 High Bluff Drive, Suite 107 San Diego, CA 92130 US Other 510(k) Applications for this Company
Contact	John Slate Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	ORZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/01/2017
Decision Date	12/26/2017
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