510(k) K252464 ยท NBL Light-Induced Fluorescence Caries Detector
Surgical Microscope (OMS2360, OMS2380)
| Applicant | Zumax Medical Co., Ltd., Suzhou, CN |
| Decision | Substantially Equivalent, Apr 28, 2026 |
| Received | Aug 6, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252464
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.