510(k) K083500 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, Feb 12, 2009 |
| Received | Nov 25, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083500
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 1, 2019 | Dornier Medtech America, Inc. Dornier Diode Laser Fibers:Used with Dornier Medilas D Family Lasers
Part Number/Description:
K1001291 600 micron single use fiber
K2011824 600 micron single use fiber
K1001293 600 micron single use f Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.