510(k) K100384 ยท GEX Powered Laser Surgical Instrument
FIBERLASE C02 LASER WAVEGUIDE
| Applicant | Lumenis, Ltd., Kfar Saba, IL |
| Decision | Substantially Equivalent, Apr 12, 2010 |
| Received | Feb 16, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K100384
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.