510(k) K121162 ยท GEX Powered Laser Surgical Instrument
POLARIS Q-SWITCH RUBY SYSTEM
| Applicant | Sandstone Medical Technologies, LLC, Birmingham AL, US |
| Decision | Substantially Equivalent, Jul 18, 2012 |
| Received | Apr 17, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121162
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.