510(k) K183122 ยท GEX Powered Laser Surgical Instrument
810nm Diode Laser System
| Applicant | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd, Shanghai, CN |
| Decision | Substantially Equivalent, Aug 25, 2019 |
| Received | Nov 9, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183122
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.