510(k) K082809 ยท GEX Powered Laser Surgical Instrument
ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM
| Applicant | Lumenis, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Dec 18, 2008 |
| Received | Sep 24, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082809
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.