510(k) K112031 ยท GEX Powered Laser Surgical Instrument
ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATION
| Applicant | Alma Lasers, Inc., Buffalo Grove IL, US |
| Decision | Substantially Equivalent, Sep 13, 2011 |
| Received | Jul 15, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112031
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.