510(k) K202601 ยท GEX Powered Laser Surgical Instrument
Single-use Sterile medical laser fiber
| Applicant | Realton (Suzhou) Medical Technology Co., Ltd., Suzhou, CN |
| Decision | Substantially Equivalent, Dec 15, 2020 |
| Received | Sep 8, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202601
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.