K210300 is an FDA 510(k) clearance for the VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System. This device is classified as a Accessories, Solution, Ultrasonic Cleaners For Lenses (Class II - Special Controls, product code LYL).
Submitted by Vuesonic, LLC (Miami Beach, US). The FDA issued a Cleared decision on April 1, 2021, 57 days after receiving the submission on February 3, 2021.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5928.
| 510(k) Number | K210300 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 03, 2021 |
| Decision Date | April 01, 2021 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | LYL - Accessories, Solution, Ultrasonic Cleaners For Lenses |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5928 |