510(k) K003955 ยท GEX Powered Laser Surgical Instrument
LASEREX INTEGRE, MODEL LP2532
| Applicant | Ellex Medical Pty, Ltd., Adelaide, South Australia, AU |
| Decision | Substantially Equivalent, Mar 15, 2001 |
| Received | Dec 21, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003955
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.