510(k) K990043 ยท GEX Powered Laser Surgical Instrument
SMOOTHLASE ALEXANDRITE LASER SYSTEM
| Applicant | Leisegang Medical, Inc., Boca Raton FL, US |
| Decision | Substantially Equivalent, Feb 11, 1999 |
| Received | Jan 6, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990043
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.