510(k) K241646 ยท GEX Powered Laser Surgical Instrument
ORTIV (ORTIV-BL, ORTIV-WH)
| Applicant | Mvitro Co., Ltd., Seoul, KR |
| Decision | Substantially Equivalent, Nov 1, 2024 |
| Received | Jun 7, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K241646
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.