510(k) K113588 ยท GEX Powered Laser Surgical Instrument
SPECTRA LASER SYSTEM
| Applicant | Lutronic Corporation, Trevose PA, US |
| Decision | Substantially Equivalent, Feb 22, 2012 |
| Received | Dec 5, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113588
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.