510(k) K053161 ยท GEX Powered Laser Surgical Instrument
SIROLASER
| Applicant | Sirona Dental Systems GmbH, Bensheim, DE |
| Decision | Substantially Equivalent, Jan 18, 2006 |
| Received | Nov 14, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053161
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.