510(k) K201724 ยท MXK Device, Analysis, Anterior Segment
Pentacam AXL Wave
| Applicant | Oculus Optikgerate GmbH, Wetzlar, DE |
| Decision | Substantially Equivalent, Oct 21, 2020 |
| Received | Jun 23, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201724
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 30, 2023 | Oculus Optikgeraete GMBH Oculus Pentacam AXL Wave, Ref 70020, CE 0123 Open, Classified |
MXK | None listed |
| Jul 8, 2022 | Oculus Optikgeraete GMBH Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye. Open, Classified |
MXK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.