510(k) K190542 ยท GEX Powered Laser Surgical Instrument
Soliton Acoustic Wave Device
| Applicant | Soliton, Inc., Houston TX, US |
| Decision | Substantially Equivalent, May 24, 2019 |
| Received | Mar 4, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190542
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.