510(k) K100487 ยท ONG Powered Laser Surgical Instrument With MicrobeamFractional Output
EQUINOX CO2 LASER SYSTEM
| Applicant | Eclipsemed Global, Inc., Dallas TX, US |
| Decision | Substantially Equivalent, Nov 29, 2010 |
| Received | Feb 19, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100487
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.