510(k) K172645 ยท ORZ Eyelid Thermal Pulsation System
iLux Instrument, iLux Disposable
| Applicant | Tear Film Innovations, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Dec 26, 2017 |
| Received | Sep 1, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172645
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.