510(k) K100035 ยท GEX Powered Laser Surgical Instrument
MODEL VISULAS 532S LASER WITH THE VITE OPTION
| Applicant | Carl Zeiss Meditec, AG, Dublin CA, US |
| Decision | Substantially Equivalent, Mar 17, 2010 |
| Received | Jan 6, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K100035
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.