Myopia Master
Device, Analysis, Anterior Segment
OCULUS Optikgeräte GmbH
The following data is part of a premarket notification filed by Oculus Optikgeräte Gmbh with the FDA for Myopia Master.
Pre-market Notification Details
| Device ID | K202989 |
| 510k Number | K202989 |
| Device Name: | Myopia Master |
| Classification | Device, Analysis, Anterior Segment |
| Applicant | OCULUS Optikgeräte GmbH Münchholzhäuser Straße 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 | 2020-09-30 |
| Decision Date | 2021-07-14 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049584029959 | K202989 | 000 |
| 04049584029942 | K202989 | 000 |
Trademark Results [Myopia Master]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MYOPIA MASTER 79262965 not registered Live/Pending |
Oculus Optikgeräte GmbH 2019-03-18 |
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