K201069 is an FDA 510(k) clearance for the VibrantVue Scleral Saline. This device is classified as a Products, Contact Lens Care, Rigid Gas Permeable (Class II - Special Controls, product code MRC).
Submitted by Dry Eye Innovations, LLC (Oak Brook, US). The FDA issued a Cleared decision on July 31, 2020, 100 days after receiving the submission on April 22, 2020.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5918.
| 510(k) Number | K201069 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 22, 2020 |
| Decision Date | July 31, 2020 |
| Days to Decision | 100 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | MRC - Products, Contact Lens Care, Rigid Gas Permeable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5918 |