510(k) K013864 ยท GEX Powered Laser Surgical Instrument
MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-60
| Applicant | Nidek, Inc., Lake Forest CA, US |
| Decision | Substantially Equivalent, Feb 8, 2002 |
| Received | Nov 21, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013864
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.