510(k) K202828 ยท GEX Powered Laser Surgical Instrument
Surgical Green Laser System
| Applicant | Realton (Suzhou) Medical Technology Co., Ltd., Suzhou, CN |
| Decision | Substantially Equivalent, Jun 4, 2021 |
| Received | Sep 24, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202828
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.