510(k) K161357 ยท ORZ Eyelid Thermal Pulsation System
LipiFlow Thermal Pulsation System
| Applicant | Tearscience, Inc., Morrisville NC, US |
| Decision | Substantially Equivalent, Nov 4, 2016 |
| Received | May 16, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K161357
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.