510(k) K170187 ยท GEX Powered Laser Surgical Instrument
Photodynamic Therapy Device
| Applicant | Uvbiotek, LLC, Hudson NY, US |
| Decision | Substantially Equivalent, Jul 28, 2017 |
| Received | Jan 23, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170187
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.