510(k) K980201 ยท GEX Powered Laser Surgical Instrument
DIO-LIGHT LASER SYSTEM
| Applicant | Nidek, Inc., Fremont CA, US |
| Decision | Substantially Equivalent, Mar 16, 1998 |
| Received | Jan 20, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980201
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.