510(k) K053628 ยท GEX Powered Laser Surgical Instrument
LIGHTSHEER DUET LASER SYSTEM
| Applicant | Lumenis, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, Apr 7, 2006 |
| Received | Dec 29, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053628
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.