FDA 510(k) Application Details - K192623

Device Classification Name	More FDA Info for this Device
510(K) Number	K192623
Device Name	LipiFlow Thermal Pulsation System
Applicant	TearScience Inc. 1700 East St. Andrew Place Santa Ana, CA 92705 US Other 510(k) Applications for this Company
Contact	Michelle Ricafort 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	09/23/2019
Decision Date	10/22/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review