510(k) K152529 ยท GEX Powered Laser Surgical Instrument
NaturaLase CO2 Laser System
| Applicant | Focus Medical, LLC, Bethel CT, US |
| Decision | Substantially Equivalent, Feb 4, 2016 |
| Received | Sep 3, 2015 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K152529
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.