510(k) K243591 ยท OWN Confocal Optical Imaging
OPTOVISION Endoscopic Light Source Unit
| Applicant | Optosurgical, LLC, Columbia MD, US |
| Decision | Substantially Equivalent, Feb 19, 2025 |
| Received | Nov 20, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243591
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.