The following data is part of a premarket notification filed by Dry Eye Innovations, Llc with the FDA for Vibrantvue Scleral Saline.
| Device ID | K201069 |
| 510k Number | K201069 |
| Device Name: | VibrantVue Scleral Saline |
| Classification | Products, Contact Lens Care, Rigid Gas Permeable |
| Applicant | Dry Eye Innovations, LLC 1200 Harger Rd. Suite 211 Oak Brook, IL 60523 |
| Contact | Donald R. Sanders |
| Correspondent | Bret Andre EyeReg Consulting, Inc. 6119 Canter Ln West Linn, OR 97068 |
| Product Code | MRC |
| CFR Regulation Number | 886.5918 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-22 |
| Decision Date | 2020-07-31 |