510(k) K862408 ยท GEX Powered Laser Surgical Instrument
MODEL 8-B CO2 LASER FOR OPTHALMIC & ORBITAL SURG
| Applicant | Directed Energy, Inc., Los Angeles CA, US |
| Decision | Substantially Equivalent, Oct 24, 1986 |
| Received | Jun 25, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K862408
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.