510(k) K083258 ยท GEX Powered Laser Surgical Instrument
MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE
| Applicant | Dornier Medtech America, Inc., Kennesaw GA, US |
| Decision | Substantially Equivalent, Jan 30, 2009 |
| Received | Nov 4, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083258
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.