510(k) K200331 ยท GEX Powered Laser Surgical Instrument
Rapid Acoustic Pulse Device
| Applicant | Soliton, Inc., Houston TX, US |
| Decision | Substantially Equivalent, Mar 10, 2020 |
| Received | Feb 10, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K200331
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.