Alleye
Grid, Amsler
Oculocare Medical AG
The following data is part of a premarket notification filed by Oculocare Medical Ag with the FDA for Alleye.
Pre-market Notification Details
| Device ID | K180895 |
| 510k Number | K180895 |
| Device Name: | Alleye |
| Classification | Grid, Amsler |
| Applicant | Oculocare Medical AG Verena Conzett Strasse 9 Zurich, CH Zh 8004 |
| Contact | Lucas Bachmann |
| Correspondent | Allison Komiyama AcKnowledge Regulatory Strategies, LLC 2834 Hawthorn St. San Diego, CA 92104 |
| Product Code | HOQ |
| CFR Regulation Number | 886.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-05 |
| Decision Date | 2018-06-27 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EOMA32120 | K180895 | 000 |
Trademark Results [Alleye]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ALLEYE 79327169 not registered Live/Pending |
Oculocare medical AG 2021-08-10 |
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