510(k) K032357 ยท GEX Powered Laser Surgical Instrument
NOVUS TTX LASER AND DELIVERY DEVICES WITH ACCESSORIES
| Applicant | Lumenis, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, Oct 9, 2003 |
| Received | Jul 30, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032357
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.