510(k) K082407 ยท GEX Powered Laser Surgical Instrument
MODIFICATION TO ULTRALIGHT II ND: YAG LASER SYSTEM
| Applicant | Sandstone Medical Technologies, LLC, Birmingham AL, US |
| Decision | Substantially Equivalent, Feb 3, 2009 |
| Received | Aug 21, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082407
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.