510(k) K091115 ยท GEX Powered Laser Surgical Instrument
ECO2 LASER SYSTEM
| Applicant | Lutronic Corporation, North Reading MA, US |
| Decision | Substantially Equivalent, Oct 30, 2009 |
| Received | Apr 17, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K091115
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.