510(k) K161403 ยท GEX Powered Laser Surgical Instrument
A.R.C. Laser Surgical Fibers and Probes
| Applicant | A.R.C Laser GmbH, Nurnberg, DE |
| Decision | Substantially Equivalent, Aug 16, 2016 |
| Received | May 20, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161403
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.