510(k) K854386 ยท GEX Powered Laser Surgical Instrument
MODEL 20 PREVIOUSLY HAND-HELD CO2 LASER SYSTEM
| Applicant | Directed Energy, Inc., Los Angeles CA, US |
| Decision | Substantially Equivalent, Mar 28, 1986 |
| Received | Oct 31, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854386
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.