The following data is part of a premarket notification filed by Tearscience, Inc. with the FDA for Lipiflow Thermal Pulsation System.
Device ID | K161357 |
510k Number | K161357 |
Device Name: | LipiFlow Thermal Pulsation System |
Classification | Eyelid Thermal Pulsation System |
Applicant | TEARSCIENCE, INC. 5151 MCCRIMMON PARKWAY SUITE 250 Morrisville, NC 27560 |
Contact | Christy Coleman |
Correspondent | Christy Coleman TEARSCIENCE, INC. 5151 MCCRIMMON PARKWAY SUITE 250 Morrisville, NC 27560 |
Product Code | ORZ |
CFR Regulation Number | 886.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-05-16 |
Decision Date | 2016-11-04 |
Summary: | summary |