510(k) K163185 ยท HBI Illuminator, Fiberoptic, Surgical Field
OptiLux LED Illuminator
| Applicant | Isolux, LLC, Naples FL, US |
| Decision | Substantially Equivalent, Nov 21, 2016 |
| Received | Nov 14, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163185
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.