510(k) K093793 ยท GEX Powered Laser Surgical Instrument
LS-40 CO2 LASER SYSTEM MODEL LS-40
| Applicant | Sandstone Medical Technologies, LLC, Birmingham AL, US |
| Decision | Substantially Equivalent, Feb 18, 2010 |
| Received | Dec 10, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K093793
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.