510(k) K060448 ยท GEX Powered Laser Surgical Instrument
LUMENIS ONE FAMILY OF SYSTEMS; LUMENIS ONE.
| Applicant | Lumenis, Ltd., Santa Clara CA, US |
| Decision | Substantially Equivalent, Jul 6, 2006 |
| Received | Feb 21, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060448
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.