510(k) K183307 ยท GEX Powered Laser Surgical Instrument
Magma Spark Pro (Magma Spark Plus, Alpha)
| Applicant | Formatk Systems , Ltd., Tirat Carmel, IL |
| Decision | Substantially Equivalent, Dec 11, 2018 |
| Received | Nov 28, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K183307
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.