510(k) K112166 ยท GEX Powered Laser Surgical Instrument
ULTRALASE FLEXIBLE CO2 LASER WAVEGUIDE
| Applicant | W and R Investments Dba Laser Engineering, Milford MA, US |
| Decision | Substantially Equivalent, Oct 21, 2011 |
| Received | Jul 28, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112166
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.