The following data is part of a premarket notification filed by Oculus Optikgerate Gmbh with the FDA for Pentacam Axl Wave.
| Device ID | K201724 |
| 510k Number | K201724 |
| Device Name: | Pentacam AXL Wave |
| Classification | Device, Analysis, Anterior Segment |
| Applicant | OCULUS Optikgerate GmbH Munchholzhauser StraBe 29 Wetzlar, DE 35582 |
| Contact | Eckhard Loh |
| Correspondent | Randy Prebula Hogan Lovells, US LLP 555 Thirteenth Street, NW Washington, DC 20004 |
| Product Code | MXK |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-23 |
| Decision Date | 2020-10-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049584025357 | K201724 | 000 |