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FDA 510(k) Application Details - K161357
Device Classification Name
More FDA Info for this Device
510(K) Number
K161357
Device Name
LipiFlow Thermal Pulsation System
Applicant
TEARSCIENCE, INC.
5151 MCCRIMMON PARKWAY
SUITE 250
MORRISVILLE, NC 27560 US
Other 510(k) Applications for this Company
Contact
Christy Coleman
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
05/16/2016
Decision Date
11/04/2016
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
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