Panels › Ophthalmic › Product code MXK · Class 2
Device, Analysis, Anterior Segment
Regulation 886.1850
2510(k)s in 12 months (23 all time)
0recalls in 12 months (7 all time)
7recalls that name a 510(k)
Top companies in MXK
| Company | 510(k)s | Recalls |
|---|---|---|
| Oculus Optikgeraete GMBH | 0 | 7 |
| Oculus Optikgerate GmbH | 5 | 0 |
| Heidelberg Engineering | 2 | 0 |
| Oculus Optikgeräte GmbH | 2 | 0 |
| Santec Corporation | 2 | 0 |
| Sis Ag, Surgical Instrument Systems | 2 | 0 |
| Visia Imaging S.R.L. | 2 | 0 |
| Bausch & Lomb | 1 | 0 |
| Haag-Streit Holding AG | 1 | 0 |
| Intelon Optics, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 30, 2023 | Oculus Optikgeraete GMBH Oculus Myopia Master , Ref 68100, CE 0123 Open, Classified |
MXK | K202989 |
| Aug 30, 2023 | Oculus Optikgeraete GMBH Oculus Pentacam AXL , Ref 70100, CE 0123 Open, Classified |
MXK | K152311 |
| Aug 30, 2023 | Oculus Optikgeraete GMBH Oculus Pentacam AXL Wave, Ref 70020, CE 0123 Open, Classified |
MXK | K201724 |
| Jul 8, 2022 | Oculus Optikgeraete GMBH Pentacam HR REF 70900. Used to image the anterior segment of the eye. Open, Classified |
MXK | K030719 |
| 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 | K152311 |
| Jul 8, 2022 | Oculus Optikgeraete GMBH Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye. Open, Classified |
MXK | K201724 |
| 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 | K152311 |
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