510(k) K043486 ยท GEX Powered Laser Surgical Instrument
PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01
| Applicant | Topcon Medical Laser Systems, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, Mar 3, 2005 |
| Received | Dec 17, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043486
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.