510(k) K854398 ยท GEX Powered Laser Surgical Instrument
MODEL CO2 LASER SYSTEM 8B
| Applicant | Directed Energy, Inc., Los Angeles CA, US |
| Decision | Substantially Equivalent, Feb 7, 1986 |
| Received | Oct 31, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854398
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.