FDA 510(k) Application Details - K152869

Device Classification Name	Camera, Ophthalmic, Ac-Powered   More FDA Info for this Device
510(K) Number	K152869
Device Name	Camera, Ophthalmic, Ac-Powered
Applicant	TEARSCIENCE, INC. 5151 MCCRIMMON PKWY., STE 250 MORRISVILLE, NC 27650 US Other 510(k) Applications for this Company
Contact	CHRISTY COLEMAN Other 510(k) Applications for this Contact
Regulation Number	886.1120   More FDA Info for this Regulation Number
Classification Product Code	HKI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2015
Decision Date	01/14/2016
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