510(k) K042785 ยท GEX Powered Laser Surgical Instrument
MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300
| Applicant | Nidek, Inc., Lake Forest CA, US |
| Decision | Substantially Equivalent, Dec 14, 2004 |
| Received | Oct 6, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042785
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.