510(k) K152311 ยท MXK Device, Analysis, Anterior Segment
Pentacam AXL
| Applicant | Oculus Optikgerate GmbH, Wetzla, DE |
| Decision | Substantially Equivalent, Jan 20, 2016 |
| Received | Aug 14, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152311
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 30, 2023 | Oculus Optikgeraete GMBH Oculus Pentacam AXL , Ref 70100, CE 0123 Open, Classified |
MXK | None listed |
| Jul 8, 2022 | Oculus Optikgeraete GMBH Pentacam AXL REF 70100,
Pentacam HR REF 70900. Used to image the anterior segment of the eye. Open, Classified |
MXK | None listed |
| Nov 21, 2017 | Oculus Optikgeraete GMBH OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13. The firm name on the label is OCULUS Optikgerate GmbH, Made in Germany.
The Pentacam AXL is designed to ta Terminated |
MXK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.