510(k) K853319 ยท GEX Powered Laser Surgical Instrument
MINI-HALO(HAND-HELD) CO2 LASER SYSTEM
| Applicant | Directed Energy, Inc., Los Angeles CA, US |
| Decision | Substantially Equivalent, Sep 19, 1985 |
| Received | Aug 7, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853319
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.