510(k) K060338 ยท GEX Powered Laser Surgical Instrument
FAMILY OF SELECTA LASER SYSTEMS INCLUDING SELECTA 1064, SELECTA SLT, SELECTA DUET, SELECTA DUO, SELECTA TRIO
| Applicant | Lumenis, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, Mar 9, 2006 |
| Received | Feb 10, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060338
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.