510(k) K211761 ยท GEX Powered Laser Surgical Instrument
UltraLase Flexible CO2 Laser Waveguide
| Applicant | W & R Investments, LLC Dba Laser Engineering, Milford MA, US |
| Decision | Substantially Equivalent, Jul 30, 2021 |
| Received | Jun 8, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K211761
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.