510(k) K172193 · GEX Powered Laser Surgical Instrument
Modified Alma Lasers Soprano XL Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules
| Applicant | Alma Lasers, Inc., Buffalo Grove IL, US |
| Decision | Substantially Equivalent, Jan 9, 2018 |
| Received | Jul 21, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172193
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.