510(k) K160549 ยท GEX Powered Laser Surgical Instrument
MEDICAL DIODE LASER SYSTEMS
| Applicant | Wuhan Gigaa Optronics Technology Co., Ltd., East Lake Development Zone, Wuhan, CN |
| Decision | Substantially Equivalent, Apr 7, 2017 |
| Received | Feb 29, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160549
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.