510(k) K112704 ยท ORZ Eyelid Thermal Pulsation System
LIPIFLOW THERMAL PULSATION SYSTEM
| Applicant | Tearscience, Inc., Morrisville NC, US |
| Decision | Substantially Equivalent, Dec 19, 2011 |
| Received | Sep 16, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112704
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 22, 2017 | Tearscience, Inc LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile Terminated |
ORZ | None listed |
| Oct 17, 2016 | Tearscience, Inc LipiFlow thermal Pulsation System, consisting of Console and Activator, Model LFD-1100
The LipiFlow Thermal Pulsation System is intended for use by physicians as a prescription device for the applica Terminated |
ORZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.