510(k) K103667 ยท GEX Powered Laser Surgical Instrument
SAPPHIRE ST PORTABLE DIODE LASER
| Applicant | Den-Mat Holdings, LLC, Santa Maria CA, US |
| Decision | Substantially Equivalent, Dec 29, 2010 |
| Received | Dec 15, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103667
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.