The following data is part of a premarket notification filed by Oculus Innovative Sciences with the FDA for Loyon.
| Device ID | K162217 |
| 510k Number | K162217 |
| Device Name: | LOYON |
| Classification | Dressing, Wound, Drug |
| Applicant | Oculus Innovative Sciences 1129 N. McDowell Boulevard Petaluma, CA 94954 |
| Contact | Brian W. Martin |
| Correspondent | Brian W. Martin Oculus Innovative Sciences 1129 N. McDowell Boulevard Petaluma, CA 94954 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2016-08-08 |
| Decision Date | 2017-03-23 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() LOYON 79150153 4779464 Live/Registered |
Desmoid Aktiengesellschaft 2014-06-04 |