510(k) K013974 ยท GEX Powered Laser Surgical Instrument
RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-A
| Applicant | Trimedyne, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Sep 23, 2002 |
| Received | Dec 3, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013974
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.