510(k) K060304 ยท GEX Powered Laser Surgical Instrument
PHOTEX DIODE LASER SERIES, MODELS 980, 810 AND 940
| Applicant | Biotex, Inc., Houston TX, US |
| Decision | Substantially Equivalent, Mar 21, 2006 |
| Received | Feb 6, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060304
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.