The following data is part of a premarket notification filed by Oculus Optikgeräte Gmbh with the FDA for Myopia Master.
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 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04049584029959 | K202989 | 000 |
04049584029942 | K202989 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MYOPIA MASTER 79262965 not registered Live/Pending |
Oculus Optikgeräte GmbH 2019-03-18 |