510(k) K113489 ยท GEX Powered Laser Surgical Instrument
ORION
| Applicant | Asclepion Laser Technologies GmbH, Jena, Thuringia, DE |
| Decision | Substantially Equivalent, Jul 27, 2012 |
| Received | Nov 23, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113489
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.