510(k) K171648 ยท GEX Powered Laser Surgical Instrument
BM.IRIS
| Applicant | Bluecore Co., Ltd., Haeundae-Gu, KR |
| Decision | Substantially Equivalent, Sep 8, 2017 |
| Received | Jun 5, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171648
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.