510(k) K180350 ยท GEX Powered Laser Surgical Instrument
Dornier Medilas H Solvo 35 Laser
| Applicant | Dornier Medtech America, Kennesaw GA, US |
| Decision | Substantially Equivalent, Mar 7, 2018 |
| Received | Feb 8, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K180350
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.