510(k) K181019 ยท GEX Powered Laser Surgical Instrument
Diode Laser System
| Applicant | Guangzhou Huafei Tongda Technology Co., Ltd., Huadi Dadao Nan Road, Fangcun, Liwan Dis, CN |
| Decision | Substantially Equivalent, Jul 16, 2018 |
| Received | Apr 17, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181019
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.