510(k) K092197 ยท GEX Powered Laser Surgical Instrument
PHOTEX30 DIODE LASER SERIES: 980, 810, 940
| Applicant | Biotex, Inc., Houston TX, US |
| Decision | Substantially Equivalent, Oct 6, 2009 |
| Received | Jul 21, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092197
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.